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FDA 510(k)

冷熱壓縮設備（FGK002）

K 號：K222136 · 2023-03-08

申請人Suzhou Microport Rehabtech (Group) Co., Ltd.
決定日期2023-03-08
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Cryo-Thermo Compression Device (FGK002) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Microport Rehabtech (Group) Co., Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K222136. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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. The listed applicant is Suzhou Microport Rehabtech (Group) Co., Ltd.. The 510(k) number is K222136.

When did Cryo-Thermo Compression Device (FGK002) receive FDA 510(k) clearance?

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

Who is the listed applicant for Cryo-Thermo Compression Device (FGK002)?

The FDA 510(k) record lists Suzhou Microport Rehabtech (Group) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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