FDA Registration
Active
🇺🇸 United States
BIOWAVE CORPORATION
Reg #: 3004558433
·
FEI: 3004558433
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- BIOWAVE CORPORATION
- Registration Number
- 3004558433
- FEI Number
- 3004558433
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8 Knight St Ste 201
- City
- NORWALK
- State
- CT
- ZIP
- 06851
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052289
Owner / Operator
- Firm Name
- BIOWAVE CORPORATION
- Operator Number
- 9086399
- Address
- 19 Newtown Turnpike, --
- City
- Westport
- State
- CT
- Postal Code
- 06880
- Country
- US
- Correspondent
- Bradford - Siff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2007-12-08 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2015-11-19 |
| Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | NHI | Class 2 | Neurology | No | 2007-04-10 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2021-07-12 |
Proprietary Names
BioWaveHOME
BioWaveGO Rx
BioWavePENS
BioWaveGO
BioWrap Electrode Garments
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device