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FDA 510(k)

Cryo-Thermo Compression Device (FGK002)

K-Number: K222136 · 2023-03-08

ApplicantSuzhou Microport Rehabtech (Group) Co., Ltd.
Decision Date2023-03-08
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Cryo-Thermo Compression Device (FGK002) is a medical device manufactured by Suzhou Microport Rehabtech (Group) Co., Ltd.. It received FDA 510(k) clearance on 2023-03-08 under approval number K222136. 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 Cryo-Thermo Compression Device (FGK002)?

Cryo-Thermo Compression Device (FGK002) is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Suzhou Microport Rehabtech (Group) Co., Ltd.. The 510(k) number is K222136.

When was Cryo-Thermo Compression Device (FGK002) approved by the FDA?

Cryo-Thermo Compression Device (FGK002) received FDA 510(k) clearance on 2023-03-08, under approval number K222136.

What company makes Cryo-Thermo Compression Device (FGK002)?

Cryo-Thermo Compression Device (FGK002) is manufactured by Suzhou Microport Rehabtech (Group) Co., Ltd..

What is the FDA product code for Cryo-Thermo Compression Device (FGK002)?

The FDA product code for Cryo-Thermo Compression Device (FGK002) is IRP.

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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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