FDA 510(k)

Air Relax, 압축 가능한 다리 장갑 시스템 (모델: AR-1.0, AR-2.0)

K-번호: K191441 · 2021-03-05

결정일2021-03-05

제품 코드IRP

자문 위원회PM

결정Substantially Equivalent

기기 요약

Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Maxstar Industrial Co., Ltd.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K191441. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)?

Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Maxstar Industrial Co., Ltd.. The 510(k) number is K191441.

When did Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) receive FDA 510(k) clearance?

Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) received FDA 510(k) clearance on 2021-03-05, under 510(k) number K191441.

Who is the listed applicant for Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)?

The FDA 510(k) record lists Maxstar Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)?

The FDA product code for Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) is IRP.

Maxstar Industrial Co., Ltd.를 신청인으로 등재한 기타 기록

K173158Air Relax

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