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FDA 510(k)

Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)

K-Number: K191441 · 2021-03-05

ApplicantMaxstar Industrial Co., Ltd.
Decision Date2021-03-05
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Maxstar Industrial Co., Ltd.. The 510(k) number is K191441.

When was Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) approved by the FDA?

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

What company makes 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 manufactured by Maxstar Industrial Co., Ltd..

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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Other Devices by Maxstar Industrial Co., Ltd.

K173158Air Relax

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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