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FDA 510(k)

Air Relax

K-Number: K173158 · 2019-05-30

ApplicantMaxstar Industrial Co., Ltd.
Decision Date2019-05-30
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Relax is a medical device manufactured by Maxstar Industrial Co., Ltd.. It received FDA 510(k) clearance on 2019-05-30 under approval number K173158. 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?

Air Relax is a medical device that received FDA 510(k) clearance on 2019-05-30. It is manufactured by Maxstar Industrial Co., Ltd.. The 510(k) number is K173158.

When was Air Relax approved by the FDA?

Air Relax received FDA 510(k) clearance on 2019-05-30, under approval number K173158.

What company makes Air Relax?

Air Relax is manufactured by Maxstar Industrial Co., Ltd..

What is the FDA product code for Air Relax?

The FDA product code for Air Relax is IRP.

Other Devices by Maxstar Industrial Co., Ltd.

K191441Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)

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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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