# Newwave Medical, LLC

- Location (FDA's records): Plano, TX
- FDA decisions: 3 (1999–2004): 3 510(k) clearances
- Product codes: LIH (1), GXY (1), IPF (1)
- Predicates its devices cite: 3 (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 whose devices it cites most
- Scientific Medical Devices, Inc.: 1 (https://510kreport.com/company/scientific-medical-devices)
- Prizm Medical, Inc.: 1 (https://510kreport.com/company/prizm-medical)
- Staodyne, Inc.: 1 (https://510kreport.com/company/staodyne)

## Firms that cite its devices most
- Armstrong Industries, Inc. Dha Mediquip Int. Dha S: 2 (https://510kreport.com/company/armstrong-industries-dha-mediquip-int-dha-s)

## Its most-cited devices
- K003631: Smartwave IF 2000 (2001), cited by 1
- K041063: Smartwave MS 2000 (2004), cited by 1

## Recent decisions
- K041063: Smartwave MS 2000 (Dec 1, 2004)
- K003631: Smartwave IF 2000 (Aug 10, 2001)
- K993130: Ultra-Garment Electrode (Dec 17, 1999)

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