# Bioinfinity (M) Sdn. Bhd.

- Location (FDA's records): Kepong, MY
- FDA decisions: 2 (2014–2017): 2 510(k) clearances
- Product codes: HIR (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 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
- Colonial Medical Supply: 1 (https://510kreport.com/company/colonial-medical-supply)

## Firms that cite its devices most
- Pelvital USA, Inc.: 1 (https://510kreport.com/company/pelvital-usa)

## Its most-cited devices
- K162689: Vibrance Pelvic Trainer (2017), cited by 1
- K141893: Vibrance Kegel Device (VKD) (2014), cited by 1

## Recent decisions
- K162689: Vibrance Pelvic Trainer (Jun 8, 2017)
- K141893: Vibrance Kegel Device (VKD) (Dec 18, 2014)

Source page: https://510kreport.com/company/bioinfinity-m-sdn-bhd