# Sanuwave, Inc.

- Location (FDA's records): Alpharetta, GA
- FDA decisions: 2 (2000–2017): 1 De Novo grant and 1 original PMA approval
- Product codes: PZL (1), NBN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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 that cite its devices most
- Storz Medical AG: 1 (https://510kreport.com/company/storz-medical)
- Tissue Regeneration Technologies, LLC: 1 (https://510kreport.com/company/tissue-regeneration-technologies)

## Its most-cited devices
- DEN160037: dermaPACE System (2017), cited by 2

## Recent decisions
- DEN160037: dermaPACE System (Dec 28, 2017)
- P990086: Healthtronics Ossatron (Oct 12, 2000)

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