Cleared Special

Cryon-X Cold Compression

K253150 · Jkh Health Co., Ltd. · Physical Medicine
Oct 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K253150 is an FDA 510(k) clearance for the Cryon-X Cold Compression, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 24, 2025, 29 days after receiving the submission on September 25, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K253150 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IRP — Massager, Powered Inflatable Tube
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5650

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