Cleared Traditional

Air Compression Therapy Device, model: ST-502

K213745 · Shenzhen Future Electronic Co., Ltd. · Physical Medicine
Mar 2022
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K213745 is an FDA 510(k) clearance for the Air Compression Therapy Device, model: ST-502, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Shenzhen Future Electronic Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 31, 2022, 122 days after receiving the submission on November 29, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K213745 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2021
Decision Date March 31, 2022
Days to Decision 122 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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