# K230167: BACK 4

- Pathway: 510(k) (Traditional)
- Applicant: Swims America Corp
- Decided: Sep 14, 2023 after 237 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K943450 (1995). 328 ancestors in all.
No later device cites it as a predicate yet.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214090: Back 3 COLOR, Swims America Corp (2022) Summary page 4.
- K210877: Evolve System with the T3 Applicator, InMode, Ltd. (2021) Summary page 4.

## Indications for use
The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions. The BACK 4 device in RF mode 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 BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BACK 4 device in EMS mode is intended for: *Prevention or retardation of disuse atrophy *Increasing local blood circulation *Muscle re-education *Maintaining or increasing range of motion. The RF treatment mode and EMS mode should not be used in combination or sequentially.

Source page: https://510kreport.com/device/K230167
Methodology: https://510kreport.com/methodology