# K061001: Thermassage

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Oct 12, 2006 after 184 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850851 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990445: LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator, Lpg USA, Inc. (2000) Summary page 1.

## Indications for use
The TherMassager is indicated for use in: • Relief of minor muscle aches and pains • Relief of muscle spasm • Temporary improvement of local circulation (i.e., blood circulation) • Temporary improvement in the appearance of cellulite

Source page: https://510kreport.com/device/K061001
Methodology: https://510kreport.com/methodology