Cleared Special

Cold Compression

K240986 · Jkh Health Co., Ltd. · Physical Medicine
May 2024
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K240986 is an FDA 510(k) clearance for the 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 May 1, 2024, 21 days after receiving the submission on April 10, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K240986 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2024
Decision Date May 01, 2024
Days to Decision 21 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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