# K063568: Hwato TDP Heat Lamp, Models TDP11-DL, TDP12-XL and TDP-22XL

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Medical Appliance Factory
- Decided: Mar 22, 2007 after 114 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
HWATO TDP Heat Lamp, including TDPlI-DL, TDPI2-XL, and TDP-22XL, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K063568
Methodology: https://510kreport.com/methodology