Cleared Special

K243644 - Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
(FDA 510(k) Clearance)

K243644 · Ceragem Co., Ltd. · Physical Medicine

Jan 2025

Decision

43d

Days

Class 2

Risk

K243644 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302), 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 January 8, 2025, 43 days after receiving the submission on November 26, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number	K243644 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2024
Decision Date	January 08, 2025
Days to Decision	43 days
Submission Type	Special
Review Panel	Physical Medicine (PM)
Summary	Statement