# K214090: Back 3 COLOR

- Pathway: 510(k) (Traditional)
- Applicant: Swims America Corp
- Decided: Nov 1, 2022 after 308 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.
2 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)
- K162828: Winback Back 3SE, Winback USA Corp (2017) Summary page 5.

## Most influential descendants
- K230167: BACK 4 (2023), 0 descendants of its own
- K230037: BACK 3 (2023), 0 descendants of its own

## Indications for use
The BACK3 COLOR device is 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 BACK3 COLOR massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K214090
Methodology: https://510kreport.com/methodology