Cleared Traditional

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

K202937 · Ceragem Co., Ltd. · Physical Medicine
Mar 2021
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K202937 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. (Chennan-Si, KR). The FDA issued a Cleared decision on March 18, 2021, 169 days after receiving the submission on September 30, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K202937 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2020
Decision Date March 18, 2021
Days to Decision 169 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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