Cleared Traditional

K210281 - Fist Assist Devices Model FA-1

K210281 is an FDA 510(k) clearance for Fist Assist Devices Model FA-1, manufactured by Fist Assist Devices, LLC. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K210281 · Fist Assist Devices, LLC · Physical Medicine device
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Jun 2021
Decision
136d
Days
Class 2
Risk

K210281 is an FDA 510(k) clearance for the Fist Assist Devices Model FA-1. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Fist Assist Devices, LLC (Los Altos, US). The FDA issued a Cleared decision on June 17, 2021 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Fist Assist Devices, LLC devices

FDA 510(k) Submission Details - K210281

510(k) Number K210281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date June 17, 2021
Days to Decision 136 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 115d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 99
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