# K011768: Thermo-Therapy, Models TT-101, TT-201, and TT-202

- Pathway: 510(k) (Traditional)
- Applicant: Thermo-Electric Co.
- Decided: Aug 3, 2001 after 57 days
- Product code: LSB (Unit, Fluidotherapy)
- Device class: 2
- Regulation: 21 CFR 890.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871802 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871802: Model K210 and K211 Fluidotherapy Units, Henley Intl. (1987) Summary page 1.
- K896817: Model T11 Fluidotherapy Unit, Henley Intl. (1991) Summary page 1.

## Indications for use
Increase of Local Blood Circulation. Treatment of Range of Motion when combined with exercise. Treatment for minor pain and stiffness of non—rheumatoid arthritis.

Source page: https://510kreport.com/device/K011768
Methodology: https://510kreport.com/methodology