# K040031: Ceragem-C Thermal Acupressure Massager

- Pathway: 510(k) (Traditional)
- Applicant: Ceragem Co., Ltd.
- Decided: Jul 28, 2004 after 202 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: 3 generations back to K993461 (2000). 4 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032449: Thermassage Energy Product, Model HY5000, Migun Medical Instrument Co., Ltd. (2003) Summary page 1.

## Most influential descendants
- K140592: Ceragem Automatic Thermal Massager (2014), 4 descendants of its own
- K062476: Ceragem RH1 Automatic Thermal Massager (2006), 3 descendants of its own
- K202937: Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 (2021), 2 descendants of its own
- K220572: Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (2022), 1 descendant of its own
- K080554: Inarex, Model 2D-LX (2008), 1 descendant of its own

## Indications for use
The intended use of the CERAGEM-C Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the Ceragem-C Thermal Massager provides radiant infrared heat for; 0 temporary relief of minor muscle and joint pain, and stiffness 0 the temporary relief of minor joint pain associated with arthritis 0 the temporary increase in local circulation where applied 0 relaxation of muscles

Source page: https://510kreport.com/device/K040031
Methodology: https://510kreport.com/methodology