Air Compressible Limb Therapy System— 510(k) K150033

Name: FDA 510(k) clearance K150033
Creator: U.S. Food and Drug Administration
Published: 2015-04-20

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K150033 for Air Compressible Limb Therapy System, Substantially Equivalent on 2015-04-20. Applicant: Daesung Maref Co., Ltd.. Device class: 2.

Clearance details

Applicant: Daesung Maref Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2015-01-09
Decision date: 2015-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Gunpo-Shi, KR

Download summary PDF View on FDA.gov ↗

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