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: K220572
• 510k Number: K220572
• 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 31045
• Contact: Hyeonggeun Hwang
• Correspondent: Joyce Kwon; Provision Consulting Group, Inc. 100 Barranca St. Suite 700 West Covina, CA 91791
• Product Code: JFB
• CFR Regulation Number: 890.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-02-28
• Decision Date: 2022-06-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809494000099	K220572	000
08809494000082	K220572	000