Cleared Traditional

Cold/Hot Compression

K223541 · Jkh Health Co., Ltd. · Physical Medicine
Oct 2023
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K223541 is an FDA 510(k) clearance for the Cold/Hot 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 27, 2023, 336 days after receiving the submission on November 25, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K223541 FDA.gov
FDA Decision Cleared 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

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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