# 11 Health Technologies Limited

- Location (FDA's records): Borehamwood, GB
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: EXB (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 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
- 11 Health and Technologies, LLC: 1 (https://510kreport.com/company/11-health-and-technologies)
- Alfa Thermodiagnostics, Inc.: 1 (https://510kreport.com/company/alfa-thermodiagnostics)

## Recent decisions
- K181643: SmartBag (SmartPouch) (Nov 16, 2018)

Source page: https://510kreport.com/company/11-health-technologies