Cleared Traditional

Ceragem Automatic Thermal Massager (CGM MB-2401)

K250266 · Ceragem Co., Ltd. · Physical Medicine
Jul 2025
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K250266 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager (CGM MB-2401), 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 July 11, 2025, 162 days after receiving the submission on January 30, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K250266 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2025
Decision Date July 11, 2025
Days to Decision 162 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

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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