Pressure Therapy System PT1003— 510(k) K181409

Name: FDA 510(k) clearance K181409
Creator: U.S. Food and Drug Administration
Published: 2019-02-19

Substantially Equivalent

Xiamen Senyang Co., Ltd.

FDA 510(k) clearance K181409 for Pressure Therapy System PT1003, Substantially Equivalent on 2019-02-19. 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: 2018-05-30
Decision date: 2019-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinglin Xiamen, CN

Download summary PDF View on FDA.gov ↗

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