Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002849858

FEI Number

3002849858

Entity Name

CERAGEM CO., LTD.

City/State/Country

Cheonan-si, Seobuk-gu Chungnam, KR

Establishment Address

10, Jeongja 1-gil, Seonggeo-eup, Cheonan-si, Seobuk-gu Chungnam 31045, KR

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

CERAGEM CO., LTD. (Owner Number: 9039475)

Owner / Operator Contact Address

10, Jeongja 1-gil, Seonggeo-eup,, Cheonan-si, Seobuk-gu, KR-44 31041, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ceragem Automatic Thermal Massager (CGM MB-2401) Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 Ceragem Automatic Thermal Massager (CGM-MB-1902) Ceramix Mat M1; Ceramix Mat S1 Ceragem Automatic Thermal Massager, Model CGM-MB-1701 & CGM-MB-1702 Ceragem Automatic Thermal Massager, Model CGM-MB-1101 PAUSE M4 Massage Chair CELLUNIC MEDISPA PRO HEALAX I Shoulder PAUSE M8 (CGM EMCG-2404) PAUSE M10 (CGM EMCG-2403) PAUSE M6 Massage Chair PAUSE M6(s) Massage Chair Ceragem Automatic Thermal Massager (Model CGM MS-2301 / CGM MS-2302)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2025-07-24
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-07-24
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	Class 2	890.5880	2025-07-24
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-07-24
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	Class 2	890.5880	2022-06-28
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2022-06-28
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	Class 2	890.5880	2024-12-23
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2016-06-29
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	Class 2	890.5880	2021-03-23
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	Class 2	890.5880	2015-12-11
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	1999-11-01

Official Correspondent

Brian Yang

US Agent Details

Joyce Kwon Business: Provision Consulting Group, Inc. Email: ask@provisionfda.com Phone: (909) 4933276

Related Public Records

Same Entity

CERAGEM CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K821133	Durham Electric Co.	ELECTRICAL VIBRATING DEVICE	1982-07-09
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

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3002244637	THUMPER MASSAGER, INC.	MARKHAM Ontario, CA
3009341046	RAPID RELEASE TECHNOLOGIES	Costa Mesa, CA, US
3007740394	HOPSTECH INDUSTRIES LTD	Kwun Tong, Kowloon, Hong Kong, HK
3001744192	BLAINE LABS, INC.	SANTA FE SPRINGS, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002849858. Last updated year: 2026. Please use registration number 3002849858 when referencing this establishment in official correspondence.