# K250266: Ceragem Automatic Thermal Massager (CGM MB-2401)

- Pathway: 510(k) (Traditional)
- Applicant: Ceragem Co., Ltd.
- Decided: Jul 11, 2025 after 162 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-2401 is designed to provide muscle relaxation therapy by delivering heat and soothing massage to affected areas. 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 aircell leg massager is designed to provide temporary relief of minor muscle aches and pains and a temporary increase in blood circulation to the treated areas. The aircell leg massager stimulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K250266
Methodology: https://510kreport.com/methodology