Cleared Special

K253150 - Cryon-X Cold Compression (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253150 · Jkh Health Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
29d
Days
Class 2
Risk

K253150 is an FDA 510(k) clearance for the Cryon-X Cold 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 24, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jkh Health Co., Ltd. devices

Submission Details

510(k) Number K253150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2025
Decision Date October 24, 2025
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Jkh USA, LLC
Bill Quanqin Dai

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K253150.
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