# K081505: Theragem Professional T1002

- Pathway: 510(k) (Traditional)
- Applicant: Medica Health, Ltd.
- Decided: Nov 19, 2008 after 174 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- 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. The FDA summary names no predicate by number.

## Indications for use
The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a lamp indicated for adjunctive use and providing temporary relief of minor muscle and joint pain. This device helps to temporarily increase local blood circulation where applied.

Source page: https://510kreport.com/device/K081505
Methodology: https://510kreport.com/methodology