Compressible Limb and Circulation Therapy System— 510(k) K200660

Name: FDA 510(k) clearance K200660
Creator: U.S. Food and Drug Administration
Published: 2021-03-08

Substantially Equivalent

Wonjin Mulsan Co., Ltd.

FDA 510(k) clearance K200660 for Compressible Limb and Circulation Therapy System, Substantially Equivalent on 2021-03-08. Applicant: Wonjin Mulsan Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wonjin Mulsan Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2020-03-12
Decision date: 2021-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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