# K243644: Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)

- Pathway: 510(k) (Special)
- Applicant: Ceragem Co., Ltd.
- Decided: Jan 8, 2025 after 43 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2301 & CGM MB-2302 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 The Air Cell Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K243644
Methodology: https://510kreport.com/methodology