Cleared Traditional

Ceragem Automatic Thermal Massager, Model CGM-MB-1901

K202113 · Ceragem Co., Ltd. · Physical Medicine
Mar 2021
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K202113 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager, Model CGM-MB-1901, a Table, Physical Therapy, Multi Function (Class II — Special Controls, product code JFB), submitted by Ceragem Co., Ltd. (Chennan-Si, KR). The FDA issued a Cleared decision on March 2, 2021, 215 days after receiving the submission on July 30, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K202113 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2020
Decision Date March 02, 2021
Days to Decision 215 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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