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

Name: FDA 510(k) clearance K243644
Creator: U.S. Food and Drug Administration
Published: 2025-01-08

Substantially Equivalent

Ceragem Co., Ltd.

FDA 510(k) clearance K243644 for Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302), Substantially Equivalent on 2025-01-08. Applicant: Ceragem Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ceragem Co., Ltd.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 2024-11-26
Decision date: 2025-01-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Cheonan-Si, KR

Download summary PDF View on FDA.gov ↗

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