Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)— 510(k) K191441

Name: FDA 510(k) clearance K191441
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Substantially Equivalent

Maxstar Industrial Co., Ltd.

FDA 510(k) clearance K191441 for Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0), Substantially Equivalent on 2021-03-05. Applicant: Maxstar Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Maxstar Industrial Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2019-05-30
Decision date: 2021-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gimpo, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.