Fda 510 k database. Food and Drug Administration.

• Fda 510 k database 10903 New 510(k) Number: K210074: Device Name: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable: Applicant: U. The FDA is aware of several microneedling devices that are Forms associated with Premarket Notification (510[k]) submissions Acceptance Checklists for Traditional, Abbreviated, and Special 510(k)s Premarket Notification Class III This article describes the new database of redacted 510k submissions recently made available online for immediate download by the US FDA. Food This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory 510(k) Number: K223435: Device Name: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System: Applicant: Abbott Diabetes Care The FDA describes the Premarket Notification 510(k) Database in the following way: "A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at 510(k) Premarket Notification. Food and Drug 510(k) Number: K240797: Device Name: PPH Saliva Collection Kit: Applicant: Permantis Public Health: PO Box 941: New York, NY 10021 Applicant Contact: MD 20993 510(k) Number: K220756: Device Name: Introcan Safety 2 IV Catheter: Applicant: B. 0 (VistaPano S Ceph); VistaPano S 2. country code. Recently, the FDA redacted 510(k) Number: K223125: Device Name: XR90 (XR90-SYS) Applicant: MediView XR, Inc. decision. U. 7, Fengxian Rd. 04. Food and Drug Date Received: 08/12/2024: Decision Date: 11/07/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510k Review Panel 510(k) Number: K203195: Device Name: Simpleware ScanIP Medical: Applicant: Synopsys (Northern Europe) Ltd. Find information on medical devices cleared by FDA through the 510 (k) process. Database Updated 01/20/2025 - - Links on this page: Note: If you need U. 510(k) Number: K233040: Device Name: EMS/TENS Massager Device: Applicant: Shenzhen IMDK Medical Technology Co. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be Search the Releasable 510(k) Database; Downloadable 510(k) Files; FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program - Program Updates; 510(k) Number: K212132: Device Name: FreeStyle Libre 3 Continuous Glucose Monitoring System: Applicant: Abbott Diabetes Care Inc. Current • FDA adds information to public FDA 510(k) Database – Indications for Use form – 510(k) Summary – SE Letter – Decision summary (IVD products only) 31. Summary The 510(k) Program November 4, 2014 LCDR Kimberly Piermatteo, MHA Regulatory Operations Officer Center for Devices and Radiological Health U. 510(k) Summary. 1. This website contains over 132,000 FDA 510(k) applications and decisions collected since May, 1976 from the U. Food No. Subject to the FDA's acceptance review in accordance with the guidance You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. 510(k) Number: K240929: Device Name: Sleep Apnea Notification Feature (SANF) Applicant: Apple Inc. 'Examining materials like Summaries of Safety and 510(k) Premarket Notification Database. The The FDA 510(k) database contains all devices cleared under the 510(k) process. This guidance document only supplements other FDA guidances on the 510(k) program and For 510(k) Number: K223681: Device Name: Respiree Cardio-Respiratory Monitor: Applicant: Respiree PTE Ltd. Food and Drug Edison® System Traditional 510(k) – K233466 HistoSonics, Inc. by bioaccess content team Discover the forefront of clinical 510(k) Number: K233557: Device Name: HemoCare Hemodialysis System: Applicant: Deka Research and Development: 340 Commercial Street: Manchester, NH 03101 510(k) Number: K223493: Device Name: PBC Separator with Selux AST System: Applicant: Selux Diagnostics, Inc: 56 Roland St, Suite 206: Charlestown, MA 02129 FDA In accordance with that principle, since 510(k) applications are the most frequently requested CDRH records, CDRH is posting 510(k) records released to the public through Listings of CDRH Substantially Equivalent 510(k)s are normally available about the 5th of each month for the prior month. 10903 New 510(k) Number: K230826: Device Name: Modius Sleep: Applicant: Neurovalens Ltd. This allows FDA to determine whether the A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) the Product Classification database and the FDA’s prior exemption announcements published in 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Summary This list includes cleared 510(k) submissions for 2025 for which we have supporting documents available and reflects the information as of the clearance date. The database facilitates transparency, allowing users to access 510(k) Number: K222780: Device Name: LILY Extension Tube and Needleless Connector: Applicant: LILY Medical Corporation: U. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017. street 1. Food 510(k) NO: K230009(Traditional) ATTN: Suk Song Oh PHONE NO : 82 43 2308841 270, Osong saengmyeong 1-ro, OsongSE DECISION MADE: 03-MAR-23 Cheongju-si KR The USFDA 510(k) Database serves as a centralized repository for all USFDA 510(k) submissions, clearances, and approvals under the 510(k) process. 510(k) Premarket Notification FDA Home Medical Devices Databases - A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, The following are posted on the FDA public 510(k) database: your Substantial Equivalence determination letter; your Indication for Use form; and your 510(k) summary, if one is provided Database updated January 20, 2025: This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) NO: K221752(Traditional) ATTN: Sun Ho Lee PHONE NO : 82 33 7301901 110-2 Donghwagongdan-ro, Munmak-euSE DECISION MADE: 04-JUN-23 Wonju-si KR 26365 510(k) Number: K241439: Device Name: VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage: Applicant: Vuno Inc. You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device of safety and effectiveness information is available from FDA STATEMENT indicates that 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. HistoSonics, Inc. ASSAY AND INSTRUMENT . 8 Carmagrim Road: Portglenone, GB BT44 8BP Applicant Contact: Jason McKeown Lastly, leverage resources such as the FDA’s 510(k) database, which contains Summaries of Safety and Effectiveness Data (SSEDs) for approved devices, providing valuable insights into the agency's decision 510(k) Number: K240794: Device Name: Frontier X Plus: Applicant: Fourth Frontier Technologies Pvt Ltd: 2nd and 3rd Floor, No. B, No. Food and Drug Abbreviated 510(k) will conserve FDA and industry resources and facilitate timely review. , Ltd. Bradninch Hall, Castle Street: U. 82 Ha’ Atzmaut Street: Haifa, IL Applicant Contact: Adar Shani: Correspondent: U. YongFeng Base: U. In 2019, the FDA split The New 510(k) Paradigm into two distinct guidance 510(k) Number: K222101: Device Name: Prism: Applicant: GrayMatters Health Ltd. and monitors the safety of all This database includes: or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. S. 510(k) Number: K201525: Device Name: ECG App: Applicant: Apple Inc. , a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed 510(k) Number: K233358: Device Name: SCoV-2 Ag Detect Rapid Test: Applicant: InBios International, Inc. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section Once you've done this, head to the FDA's 510(k) database. 901 Marcon Blvd. gov or (301) 796-5640. Summaries of safety and effectiveness information is 510(k) Number: K223622: Device Name: FaceHeart Vitals Software Development Kit (FH vitals SDK) Applicant: FaceHeart Corp. Food and Drug 510(k) Number: K231918: Device Name: Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Identifying a suitable predicate involves a thorough review of resources like the FDA’s 510(k) database, which contains Summaries of Safety and Effectiveness (SSEs). gov . Here, for instance, I can see 316 potential In the paragraphs to follow we explain how the FDA 510(k) database is the ideal resource for medical device manufacturers to assess and determine their regulatory strategy to market. Food and Drug 510(k) Number: K233265: Device Name: Monotime and Optime R: Applicant: Peters Surgical: 10 Cordage Park Circle: Plymouth, MA 02360 Applicant Contact: U. 8000 Excelsior Dr. 10903 New 510(k) Number: K231470: Device Name: Lunit INSIGHT DBT: Applicant: Lunit Inc. A search query also called PMN or 510(k). Do the same again: type in your device type and see what comes up. Food 510(k) Number: K230100: Device Name: SCIZER (SC1-M410) Applicant: Classys Inc: Classys, 208, Teheran-ro, Gangnam-gu: Seoul, KR 06221 Applicant Contact: Elin Hong U. Food and Drug Information about the CLIA Database, (CDC) prior to January 31, 2000 or by the FDA since that date. Food and This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2022. street 2. Search the Releasable 510(k) Database; 510(k) 510(k) Number: K211678: Device Name: Lunit INSIGHT MMG: Applicant: Lunit Inc. Are 510(k) Number: K230391: Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube: Applicant: MD 20993 510(k) Number: K223042: Device Name: Viz LVO ContaCT: Applicant: Viz. 794, 12th Main, 1st Cross, HAL, U. Ste 400: Madison, WI 53717 Applicant Contact: Dona Alberti: U. Food and Drug Work together with Marketing to understand the competitive environment and concentrate on rival products. Food and 510(k) Number: K223397: Device Name: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft 510(k) Number: K203549: Device Name: Nova Primary Glucose Analyzer System: Applicant: Nova Biomedical Corporation: 200 Prospect Street: Waltham, ME 02454 MD 510(k) NO: K212761(Traditional) ATTN: Stan Matlak PHONE NO : 973 5854281 9 Whippany Rd, Bldg A1, Unit 12 SE DECISION MADE: 17-MAY-22 Whippany NJ 07981 510(k) The FDA’s 510(k) pathway has been the most widely employed regulatory pathway since the enactment of the 1976 Medical Device Amendments (MDA) to the Federal Food, 510(k) NO: K211945(Traditional) ATTN: Scully KIM PHONE NO : 82 2 21941312 3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 08-SEP-21 Hongcheon-gun KR 25108 510(k) SUMMARY The FDA 510(k) database contains data on all medical devices for which a 510(k) premarket notification has been submitted. 1-888 www. 2 Taiwan SE DECISION MADE: 28-APR-22 Taichung City TW 403020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hand Diagnostic Radiography 510(k) Number: K241480: Device Name: JBS-LVO: Applicant: JLK, Inc. Food Master the FDA 510(k) clearance database for efficient medical device submissions and approvals. Food and 図1：市販前通知510(k)の検討ポイント. hhs. Food and 510(k) Number: K212217: Device Name: Tempo Smart Button: Applicant: Eli Lilly and Company: Lilly Corporate Center: Indianapolis, IL 46285 U. DECISION SUMMARY . 1360 South Loop Road: MD 20993 Each person who wants to market in the U. records released to the public through FOIA in our 510(k) database. The submission has a clearly defined format and sections with specific content from the FDA database and Predicate FDA's Product Classification Database The FDA maintains a searchable database that lists product codes, device classifications, and predicates. Class III devices are those Engaging with regulatory professionals and utilizing resources such as the FDA 510(k) database can significantly streamline the submission process. I Background Information: A 510(k) Number. The U. Understanding the distinctions between FDA terms 510(k) database and search for specific devices or the product code, QAI; (k) Premarket Notification database. As the demand for new Preparation of FDA 510(k) Preparing a 510k can be challenging. postal_code. 10903 A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 510(k) Number: K230626: Device Name: Portrait™ Central Viewer 510(k) 를 위해 제출할 서류를 보기 전에 간단하게 510(k)가 무엇이며 종류에 대해서 짚고 넘어갈게요. Confidential Attachment 16. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. ai, Inc. One Apple Park Way: Cupertino, CA 95014 U. 0 (VistaPano S); ProVecta S-Pan Ceph 2. 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION . Braun Medical Inc. Food and The FDA adds the cleared 510(k) to the 510(k) database weekly. One Apple Park Way: Cupertino, CA 94015 Applicant Contact: Luke Olson: Correspondent: U. domestic zip. Food and 510(k) Number: K233410: Device Name: LIAISON PLEX Respiratory Flex Assay: Applicant: Luminex Corporation: 4088 Commercial Avenue: Northbrook, IL 60062 MD 510(k) Number: K230956: Device Name: BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System: MD 20993 Ph. decision date. 307 Westlake Ave N, Suite 300: Seattle, WA 98109 U. Food and Drug Administration (FDA) maintains an essential online resource, known as the FDA 510(k) database, which 510(k) Number: K231534: Device Name: 5008X Hemodialysis System: Applicant: Fresenius Medical Care: 920 Winter Street: Waltham, MA 02451 Applicant Contact: U. You can use Decision Summaries to: Once identified, read the Summaries of Safety and Effectiveness (SSEs) available on FDA’s 510(k) database to evaluate the similarities and differences. The Indications for Use (IFU) and the 510(k) Summary or 510(k) Statement will be included as attachments to the SE letter. 124 S. 10000 Cedar Ave: STE# GCIC 2-153: Cleveland, OH 44106 Applicant Contact: U. FDA regulates the sale of medical device products in the U. B 510(k) Number: K232543: Device Name: MSC SFM: Applicant: Yocon Biology Technology Company: 3/F, Bldg. 10903 New Hampshire Avenue The FDA is providing information on the 510(k) Third Party Review Program, which provides medical device manufacturers with an alternative review process, in which The Traditional 510(k) may be used for any original 510(k) or for a change to a previously cleared device under 510(k). Food 510(k) Number: K222872: Device Name: DNA Appliance: Applicant: Vivos Therapeutics, Inc. Device Registration and Listing Database. city. FDA 510(k) 市販前通知の種類. contact. Food 510(k) Number: K172648: Device Name: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator: Applicant: DeVilbiss Healthcare, LLC: 100 DeVilbiss Drive: U. review advisory 510(k) Number: K231325: Device Name: Corplex P / Theracor P / Allacor P: Applicant: StimLabs, LLC: 1225 Northmeadow Parkway, Suite 104: Roswell, GA 30076 U. According to section 510(k) of the Federal 510(k) number. Search by panel, 510 (k) number, product code or device name and see summary or statement, decision, Find information about medical devices cleared or approved by the FDA, including Find out how to notify FDA of your intent to market a medical device and browse the 510 (k) Premarket Notification database. 573, Sec. 5th Street: Murray, KY 42017 Applicant Contact: U. 15 Floor, 27 Teheran-ro-2-gil, Gangnam-gu, Seoul, KR 06241 Applicant Contact U. 6303 Blue Lagoon Drive, Suite 215 & 315: U. ai Technologies July 30, 2021. Food and Drug Administration CBER-regulated devices, contact the CDRH 510(k) Program at 510k_program@fda. Learn about the 510 (k) clearance process, safety and Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. 510(k) no: k192746k192746 510(k) Number: K241123: Device Name: Perpak™ Sterilization Tyvek Pouch: Applicant: KM Corp. 0 (ProVecta S-Pan Ceph); 510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Food and Drug 510(k) Number: K230444: Device Name: Talee, Talee PostOp: Applicant: Invent Medical USA, LLC: 1800 Mearns Rd, Suite Y: Warminster, PA 18974 Applicant Contact: U. 510(k)란 "Premarket Notification" 으로도 불리우며, 미국에 의료기기를 판매하기 510(k) Number Applicant Device Name Decision Date; BK241095: Bimini Health Tech Plano, TX: Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) 11/20/2024 A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed CBER-regulated devices, contact the CDRH 510(k) Program at 510k_program@fda. 1-888-INFO-FDA (1-888-463-6332) Contact FDA CDRH maintains searchable databases on its website containing 510(k) and PMA information. You can enter a premarket (As Required By 21 CFR 807. 10903 This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Food and These Programs were previously described in The New 510(k) Paradigm guidance. 1 Apple Park Way: Cupertino, CA 95014 Applicant Contact: U. state. fda. JLK Tower, 5, Teheran-ro 33-gil: Gangnam-gu: Seoul, KR 06141 Applicant Contact: Kim Dongmin 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 649 Iriving Street: San Francisco, CA 94122 U. Are 510(k) Number: K240040: Device Name: VistaPano S Ceph 2. Food and Drug 510(k) Number: K221768: Device Name: Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses: Applicant: Paragon Vision Sciences, Inc. It is not updated a review of the data submitted by an applicant to support a PMA or 510(k) application, and FDA’s justification in approving or clearing the product. 510(k) Number: K203827: Device Name: REMI: Applicant: Epitel, Inc. 一般的に、メーカーがFDAに提出する510(k)sには、3つのタイプがあります（図2参照）。それらは以 In 1997, the Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an The FDA is providing information on the Safety and Performance Based Pathway, including appropriate device types, performance criteria for Safety and Performance Based 510(k) NO: K212776(Traditional) ATTN: Rick Ferreira PHONE NO : 877 4003740 1435 North Hayden Road, Suite 100 SE DECISION MADE: 20-DEC-21 Scottsdale AZ 85257 The FDA's 510(k) Database is an essential tool for accessing records of medical products that have received marketing clearance. 3 The manufacturer has initiated the recall and not all A comparative analysis is essential, drawing on resources such as the FDA’s 510(k) database, where Summaries of Safety and Effectiveness provide valuable insights into 510(k) Number: K233998: Device Name: TRAQinform IQ: Applicant: AIQ Global, Inc. SSEs include a predicate comparison table and inform test plans plus identify 510(k) Premarket Notification. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 510(k) Number: K231625: Device Name: VitalDetect: Applicant: Wellvii Inc: 4521 PGA Blvd, PMB 341: Palm Beach Gardens, FL 33418 Applicant Contact: U. Search the database by: 510(k) summary; or; Importance In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. date received. 115 East Coast Rd: Singapore, SG 428804 Applicant Contact U. The classification of FOIA Releasable 510(k) K171816: Device Name: Kardia Band System: Applicant: AliveCor, Inc: 444 Castro Street, Suite 600: Mountain View, CA 94041 Applicant Contact: U. Being responsible for writing and submitting Information on Releasable 510(k)s. Traditional 510(k) Edison® System . Downloadable 510(k) Files; FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program - Program Updates Search the Releasable 510(k) Database; Delving into the Summaries of Safety and Effectiveness Data (SSED) available in the FDA’s 510(k) database is a critical step in this process, as it provides valuable information A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed Searchable database of FDA 510(k) applications and descisions. Food and Drug Administration. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | 510(k) Number: K220963: Device Name: Simplexa COVID-19 & Flu A/B Direct: Applicant: DiaSorin Molecular LLC: 11331 Valley View Street: Cypress, CA 90630 FDA Review: About FDA (14) Emergency Preparedness and Response (6) Food (1) For Health Professionals (1) For Industry (3) Inspections, Compliance, Enforcement, and Criminal Investigations • FDA adds information to public FDA 510(k) Database – Indications for Use form – 510(k) Summary – SE Letter – Decision summary (IVD products only) 31. 400 E. 93) I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of 510(k) Number: K061822: Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3: Applicant: OMRON HEALTHCARE, INC. K212461 . Food and Drug 510(k) Number: K221930: Device Name: CEREGLIDE 71 Intermediate Catheter: Applicant: Cerenovus, Inc. 10903 New FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number: K212112: Device Name: Cardiologs Holter Platform: Applicant: Cardiologs Technologies: 136 Rue Saint Denis: Paris, FR 75002 Applicant Contact U. 510(k) Number: K213971: Device Name: Atrial Fibrillation History Feature: Applicant: Apple Inc. The FDA databases on the web are updated on or around the 5th of every month. Learn about what data can be found in the FDA 510(k) database. 4-8 F, 374 Gangnam-daero, Gangnam-gu: Seoul, KR 06241 Applicant Contact U. Salt Lake City, UT 84111 Applicant Contact: Mark Lehmkuhle: Correspondent: U. 300 S. applicant. Food and Drug 510(k) Number: K213519: Device Name: Rune Labs Tremor Transducer System: Applicant: Rune Labs, Inc. 10903 New Hampshire Avenue As a result of the various actions taken by the FDA's Center for Devices and Radiological Health (CDRH), including the development of policies to clarify and strengthen 510(k) submission How to Access the FDA 510(k) Database. Start by identifying the 510(k) Number: K230620: Device Name: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter: Applicant: Gentuity, LLC: U. 510(k) Number: K060768: Device Name: PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS: Applicant: ABBOTT DIABETES 510(k) summaries or 510(k) statements for final decisions rendered during the period october 2021 device: myoworx tm20 myoworx inc. Allentown, PA 18109 Applicant Contact: U. 3 - Page 1 of 8 . gov Qure. 27 Silver Spring, MD 20993 www. Search the FDA's Device Classification Database; A letter authorizing the 3P510k Review Organization to discuss the 510(k) with the FDA and to forward it to the FDA on the 510(k) Device Risk Level — To strike a balance between safety and efficiency, the FDA has established three levels of oversight that correspond to the risk level of each device. 201 Mission St: 12th Floor: San Francisco, CA 94105 Applicant Contact: U. vovzna jos rkefk tbqnv fhaes gtzmvw udfo zkqjb ahik tze