# 9th Wave, Inc.

- Location (FDA's records): Mt Pleasant, SC
- FDA decisions: 3 (1996–1997): 3 510(k) clearances
- Product codes: FNM (3)
- 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
- K963620: 9TH Wave Models 500 & 550 Low Air Loss Systems (Jan 7, 1997)
- K963677: 9TH Wave Model 200 Alternating Pressure Pad (Nov 26, 1996)
- K963626: 9TH Wave Models 400 & 450 Alternating Pressure Mattress (Nov 26, 1996)

Source page: https://510kreport.com/company/9th-wave