Cleared Special

Ceragem Automatic Thermal Massager (CGM-MB-1902)

K243355 · Ceragem Co., Ltd. · Physical Medicine
Nov 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K243355 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager (CGM-MB-1902), 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 November 27, 2024, 29 days after receiving the submission on October 29, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K243355 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2024
Decision Date November 27, 2024
Days to Decision 29 days
Submission Type Special
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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