COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)— 510(k) K080134

Name: FDA 510(k) clearance K080134
Creator: U.S. Food and Drug Administration
Published: 2009-01-23

Substantially Equivalent

Wonjin Mulsan Co., Ltd.

FDA 510(k) clearance K080134 for COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000), Substantially Equivalent on 2009-01-23. 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: 2008-01-18
Decision date: 2009-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Mirada, CA, US

Download summary PDF View on FDA.gov ↗

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