Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702

Table, Physical Therapy, Multi Function

Ceragem Co, Ltd.

The following data is part of a premarket notification filed by Ceragem Co, Ltd. with the FDA for Ceragem Automatic Thermal Massager Model Cgm-mb-1701 & Cgm-mb-1702.

Pre-market Notification Details

• Device ID: K202937
• 510k Number: K202937
• Device Name: Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
• Classification: Table, Physical Therapy, Multi Function
• Applicant: Ceragem Co, Ltd. 10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu Cheonan-si, KR 31041
• Contact: Hyeonggeun Hwang
• Correspondent: Priscilla Chung; LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620
• Product Code: JFB
• CFR Regulation Number: 890.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-30
• Decision Date: 2021-03-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809494000099	K202937	000
08809494000082	K202937	000