Cleared Traditional

Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702

K220572 · Ceragem Co., Ltd. · Physical Medicine
Jun 2022
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K220572 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702, a Table, Physical Therapy, Multi Function (Class II — Special Controls, product code JFB), submitted by Ceragem Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on June 17, 2022, 109 days after receiving the submission on February 28, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K220572 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2022
Decision Date June 17, 2022
Days to Decision 109 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code JFB — Table, Physical Therapy, Multi Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5880

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