Air compression therapy system FO-3001; Air compression therapy system FO-3008— 510(k) K201982

Name: FDA 510(k) clearance K201982
Creator: U.S. Food and Drug Administration
Published: 2021-03-25

Substantially Equivalent

Foshan Hongfeng Co., Ltd.

FDA 510(k) clearance K201982 for Air compression therapy system FO-3001; Air compression therapy system FO-3008, Substantially Equivalent on 2021-03-25. Applicant: Foshan Hongfeng Co., Ltd.. Device class: 2.

Clearance details

Applicant: Foshan Hongfeng Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2020-07-17
Decision date: 2021-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

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