# Swims America Corp

- Location (FDA's records): White Plains, NY
- FDA decisions: 4 (2022–2023): 4 510(k) clearances
- Product codes: PBX (3), IPF (1)
- 510(k) review time since 2016: median 273 days, against 241 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Winback USA Corp: 2 (https://510kreport.com/company/winback-usa)
- InMode, Ltd.: 2 (https://510kreport.com/company/inmode)

## Its most-cited devices
- K214090: Back 3 COLOR (2022), cited by 2

## Recent decisions
- K230167: BACK 4 (Sep 14, 2023)
- K230037: BACK 3 (Jul 19, 2023)
- K220014: Rshock (Mar 1, 2023)
- K214090: Back 3 COLOR (Nov 1, 2022)

Source page: https://510kreport.com/company/swims-america