Cleared Traditional

K223541 - Cold/Hot Compression

K223541 is an FDA 510(k) clearance for Cold/Hot Compression, manufactured by Jkh Health Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K223541 · Jkh Health Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
336d
Days
Class 2
Risk

K223541 is an FDA 510(k) clearance for the Cold/Hot Compression. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 27, 2023 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Health Co., Ltd. devices

FDA 510(k) Submission Details - K223541

510(k) Number K223541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2022
Decision Date October 27, 2023
Days to Decision 336 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 115d · This submission: 336d
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 K223541.
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