Ceragem Automatic Thermal Massager (CGM-MB-1902)— 510(k) K243355

Name: FDA 510(k) clearance K243355
Creator: U.S. Food and Drug Administration
Published: 2024-11-27

Substantially Equivalent

Ceragem Co., Ltd.

FDA 510(k) clearance K243355 for Ceragem Automatic Thermal Massager (CGM-MB-1902), Substantially Equivalent on 2024-11-27. 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: 2024-10-29
Decision date: 2024-11-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Chennan-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.