# K232966: Fisiowarm 7.0

- Pathway: 510(k) (Traditional)
- Applicant: Golden Star Srl
- Decided: Dec 26, 2024 after 462 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K122389 (2012). 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)
- K162828: Winback Back 3SE, Winback USA Corp (2017) Summary page 6.

## Indications for use
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K232966
Methodology: https://510kreport.com/methodology