# K051875: Bioflex Prescription System and Related Treatment Heads

- Pathway: 510(k) (Traditional)
- Applicant: Meditech International, Inc.
- Decided: Mar 13, 2006 after 245 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: 5 generations back to K871179 (1987). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023621: Bioflex Professional Therapy System, Meditech International, Inc. (2003) Summary page 2.
- K041885: Bioflex LD-175 and LD-1200 Treatment Heads, Meditech International, Inc. (2005) Summary page 2.

## Most influential descendants
- K081355: Bioflex LD-R100 Treatment Head (2008), 0 descendants of its own

## Indications for use
The BioFlex"" Prescription Unit and related Treatment Heads is used by trained health care professionals and is indicated for the use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The BioFlex"" Prescription Unit and related Treatment Heads is a "multi-mode" low level light treatment system configured for multiple treatment heads and powered by a flexible protocol controller that delivers various treatment protocols.

Source page: https://510kreport.com/device/K051875
Methodology: https://510kreport.com/methodology