Pressure Therapy System— 510(k) K161907

Name: FDA 510(k) clearance K161907
Creator: U.S. Food and Drug Administration
Published: 2017-02-23

Substantially Equivalent

Xiamen Senyang Co., Ltd.

FDA 510(k) clearance K161907 for Pressure Therapy System, Substantially Equivalent on 2017-02-23. Applicant: Xiamen Senyang Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xiamen Senyang Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2016-07-12
Decision date: 2017-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinglin Xiamen, CN

Download summary PDF View on FDA.gov ↗

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