# K133981: Avacen 100

- Pathway: 510(k) (Abbreviated)
- Applicant: Avacen, Inc.
- Decided: Aug 15, 2014 after 232 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
Longest line of descent: 3 generations back to K072534 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111273: Fir Heat Theraphy Sysyems, Shenzhen Anpan Technology Co., Ltd. (2011) Summary page 6.

## Indications for use
The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.

Source page: https://510kreport.com/device/K133981
Methodology: https://510kreport.com/methodology