# K081355: Bioflex LD-R100 Treatment Head

- Pathway: 510(k) (Abbreviated)
- Applicant: Meditech International, Inc.
- Decided: Dec 18, 2008 after 218 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: 6 generations back to K871179 (1987). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051875: Bioflex Prescription System and Related Treatment Heads, Meditech International, Inc. (2006) Summary page 1.
- K041885: Bioflex LD-175 and LD-1200 Treatment Heads, Meditech International, Inc. (2005) Summary page 1.

## Indications for use
The BIOFLEX LD-R100 Treatment head device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

Source page: https://510kreport.com/device/K081355
Methodology: https://510kreport.com/methodology