# K101227: Back-Tek

- Pathway: 510(k) (Traditional)
- Applicant: York Biomedical, Inc.
- Decided: Jun 23, 2010 after 51 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 K072534 (2008). 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)
- K092589: Thermotex Platinum System, Eas Consulting Group, LLC (2010) Summary page 1.

## Indications for use
The Back-tek system is indicated for the temporary relief of minor muscle and joint pain and stiffness; and the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.

Source page: https://510kreport.com/device/K101227
Methodology: https://510kreport.com/methodology