# Biowave Corporation

- Location (FDA's records): Norwalk, CT
- FDA decisions: 8 (2005–2026): 8 510(k) clearances
- Product codes: GZJ (4), GXY (2), LIH (1), NHI (1)
- 510(k) review time since 2016: median 30 days, against 195 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 10 (6 its own); citations of its devices by later devices: 13 (6 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
- Johari Digital Healthcare, Ltd.: 1 (https://510kreport.com/company/johari-digital-healthcare)
- Media Plus, LLC: 1 (https://510kreport.com/company/media-plus)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- Vertis Neuroscience, Inc.: 1 (https://510kreport.com/company/vertis-neuroscience)

## Firms that cite its devices most
- Spr Therapeutics, Inc.: 5 (https://510kreport.com/company/spr-therapeutics)
- Shenzhen Roundwhale Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-roundwhale-technology)
- Neuromed Devices, Inc.: 1 (https://510kreport.com/company/neuromed-devices)

## Its most-cited devices
- K052289: Deepwave Neuromodulation Pain Therapy Device (2005), cited by 3
- K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System (2006), cited by 3
- K072123: Homewave Neuromodulations Pain Therapy Device (2008), cited by 2
- K203158: BioWave BioWraps (2021), cited by 2
- K152437: BiowaveHOME Neuromodulation Pain Therapy Device (2015), cited by 2
- K180943: BioWaveGO (2018), cited by 1

## Recent decisions
- K261522: BioWave BioWraps (Jun 3, 2026)
- K203158: BioWave BioWraps (Jul 8, 2021)
- K210202: BioWaveGO  RX (Feb 24, 2021)
- K180943: BioWaveGO (Aug 17, 2018)
- K152437: BiowaveHOME Neuromodulation Pain Therapy Device (Sep 25, 2015)
- K072123: Homewave Neuromodulations Pain Therapy Device (Feb 1, 2008)
- K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System (Aug 15, 2006)
- K052289: Deepwave Neuromodulation Pain Therapy Device (Dec 13, 2005)

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