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FDA 510(k)

Fist Assist Devices Model FA-1

K-Number: K210281 · 2021-06-17

ApplicantFist Assist Devices, LLC
Decision Date2021-06-17
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Fist Assist Devices Model FA-1 is a medical device manufactured by Fist Assist Devices, LLC. It received FDA 510(k) clearance on 2021-06-17 under approval number K210281. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fist Assist Devices Model FA-1?

Fist Assist Devices Model FA-1 is a medical device that received FDA 510(k) clearance on 2021-06-17. It is manufactured by Fist Assist Devices, LLC. The 510(k) number is K210281.

When was Fist Assist Devices Model FA-1 approved by the FDA?

Fist Assist Devices Model FA-1 received FDA 510(k) clearance on 2021-06-17, under approval number K210281.

What company makes Fist Assist Devices Model FA-1?

Fist Assist Devices Model FA-1 is manufactured by Fist Assist Devices, LLC.

What is the FDA product code for Fist Assist Devices Model FA-1?

The FDA product code for Fist Assist Devices Model FA-1 is IRP.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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