# K072534: Bio-Mat 2000

- Pathway: 510(k) (Traditional)
- Applicant: Richway Intl., Inc.
- Decided: Feb 8, 2008 after 154 days
- Product code: IRT (Pad, Heating, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Chung Cheng Electric Far Infrared Healthful Lamp: named in the summary without a submission number
- (no number) Lightwave Infrared Lamp: named in the summary without a submission number
- (no number) LumiWave lx4 Infrared Therapy Device: named in the summary without a submission number
- (no number) AutoPrism Infrared Lamp: named in the summary without a submission number
- (no number) KenkoWave Infrared Pain Treatment System: named in the summary without a submission number
- (no number) Health O Meter Electric Heating Pad with Massage: named in the summary without a submission number

## Most influential descendants
- K092589: Thermotex Platinum System (2010), 4 descendants of its own
- K111273: Fir Heat Theraphy Sysyems (2011), 1 descendant of its own
- K133981: Avacen 100 (2014), 0 descendants of its own
- K120254: Therasage Heating Pad (2012), 0 descendants of its own
- K101227: Back-Tek (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K072534
Methodology: https://510kreport.com/methodology