Cryo-Thermo Compression Device (FGK002)— 510(k) K222136

Name: FDA 510(k) clearance K222136
Creator: U.S. Food and Drug Administration
Published: 2023-03-08

Substantially Equivalent

Suzhou Microport Rehabtech (Group) Co., Ltd.

FDA 510(k) clearance K222136 for Cryo-Thermo Compression Device (FGK002), Substantially Equivalent on 2023-03-08. Applicant: Suzhou Microport Rehabtech (Group) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Microport Rehabtech (Group) Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2022-07-19
Decision date: 2023-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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