# Neuromodulatory Devices & Applications

- Location (FDA's records): San Diego, CA
- FDA decisions: 2 (2025–2025): 2 510(k) clearances
- Product codes: OBP (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (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
- Tonica Elektronik A/S: 1 (https://510kreport.com/company/tonica-elektronik-a-s)
- Brainsway, Ltd.: 1 (https://510kreport.com/company/brainsway)

## Its most-cited devices
- K243319: Ampa One System (AMPA-001) (2025), cited by 1

## Recent decisions
- K251210: Ampa One System (AMPA-001) (Jun 27, 2025)
- K243319: Ampa One System (AMPA-001) (Feb 13, 2025)

Source page: https://510kreport.com/company/neuromodulatory-devices-applications