Cleared Traditional

K201645 - Massage Compression Boots

K201645 is an FDA 510(k) clearance for Massage Compression Boots, manufactured by Jkh USA, LLC. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K201645 · Jkh USA, LLC · Physical Medicine device
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Sep 2020
Decision
90d
Days
Class 2
Risk

K201645 is an FDA 510(k) clearance for the Massage Compression Boots. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Jkh USA, LLC (Walnut, US). The FDA issued a Cleared decision on September 15, 2020 after a review of 90 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 Jkh USA, LLC devices

FDA 510(k) Submission Details - K201645

510(k) Number K201645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2020
Decision Date September 15, 2020
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 98
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K201645.
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