# Pelvital USA, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 5 (2020–2024): 5 510(k) clearances
- Product codes: HIR (5)
- 510(k) review time since 2016: median 29 days, against 29 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (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
- Bioinfinity (M) Sdn. Bhd.: 1 (https://510kreport.com/company/bioinfinity-m-sdn-bhd)

## Its most-cited devices
- K233362: Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (2023), cited by 1
- K212655: Flyte (2021), cited by 1

## Recent decisions
- K240805: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (Aug 1, 2024)
- K233362: Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (Dec 29, 2023)
- K212655: Flyte (Sep 21, 2021)
- K210764: Flyte (Apr 13, 2021)
- K200409: Pelvital System (Jul 10, 2020)

Source page: https://510kreport.com/company/pelvital-usa