# K202113: Ceragem Automatic Thermal Massager, Model CGM-MB-1901

- Pathway: 510(k) (Traditional)
- Applicant: Ceragem Co., Ltd.
- Decided: Mar 2, 2021 after 215 days
- Product code: JFB (Table, Physical Therapy, Multi Function)
- Device class: 2
- Regulation: 21 CFR 890.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K993461 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140592: Ceragem Automatic Thermal Massager, Ceragem International, Inc. (2014) Summary page 4.

## Indications for use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: - Temporary relief of minor muscle and joint pain stiffness - Temporary relief of minor joint pain associated with arthritis - Temporary increase in local circulation where applied - Relaxation of muscles

Source page: https://510kreport.com/device/K202113
Methodology: https://510kreport.com/methodology