# Powerful Medical, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 1 (2026–2026): 1 De Novo grant
- Product codes: SHS (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- DEN250044: Queen of Hearts (ACS AI ECG Model) (Sep 3, 2026)

Source page: https://510kreport.com/company/powerful-medical