FDA 510(k)

Air Relax, Compressível Sistemas de Braçadeira de Membro (Modelo: AR-1.0, AR-2.0)

Número K: K191441 · 2021-03-05

Data da decisão2021-03-05

Código do produtoIRP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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