Cleared Traditional

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)

K251623 · Shenzhen Yicai Health Technology Co., Ltd. · Physical Medicine
Sep 2025
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K251623 is an FDA 510(k) clearance for the Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061), a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Shenzhen Yicai Health Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 17, 2025, 112 days after receiving the submission on May 28, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K251623 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2025
Decision Date September 17, 2025
Days to Decision 112 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

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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