# Bioflex, Inc.

- Location (FDA's records): Columbus, OH
- FDA decisions: 1 (1995–1995): 1 510(k) clearance
- Product codes: GXY (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Axiobionics, LLC: 1 (https://510kreport.com/company/axiobionics)

## Its most-cited devices
- K944543: Bioflex Garments, Assorted Models (1995), cited by 1

## Recent decisions
- K944543: Bioflex Garments, Assorted Models (Jul 19, 1995)

Source page: https://510kreport.com/company/bioflex