# K080465: WS Far Infrared Therapy Unit, Model # TY-101 Series

- Pathway: 510(k) (Traditional)
- Applicant: Ws Far IR Medical Technology Co., Ltd.
- Decided: Jul 18, 2008 after 148 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
Longest line of descent: 1 generation back to K003538 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003538: TDP CQ-27 Heat Lamp, Lhasa Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K160849: WS (TM) Far-Infrared Therapy Unit, Model KP-B210 (2016), 0 descendants of its own

## Indications for use
The WSTM THERAPY UNITS, TY-101N and TY-101F, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K080465
Methodology: https://510kreport.com/methodology