# K160849: WS (TM) Far-Infrared Therapy Unit, Model KP-B210

- Pathway: 510(k) (Traditional)
- Applicant: Ws Far IR Medical Technology Co., Ltd.
- Decided: Dec 15, 2016 after 262 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: 2 generations back to K003538 (2001). 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)
- K080465: WS Far Infrared Therapy Unit, Model # TY-101 Series, Ws Far IR Medical Technology Co., Ltd. (2008) Summary page 4.

## Indications for use
The WS(TM) Far-Infrared Therapy Unit, Model: KP-B210, 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.

Source page: https://510kreport.com/device/K160849
Methodology: https://510kreport.com/methodology