FDA Registration
Active
🇺🇸 United States
BioWrap Electrode Garments
Reg #: 3004558433
·
FEI: 3004558433
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIOWAVE CORPORATION
- Registration Number
- 3004558433
- FEI Number
- 3004558433
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 KNIGHT STREET, Suite 201
- City
- NORWALK
- State
- CT
- ZIP
- 06851
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203158
Owner / Operator
- Firm Name
- BIOWAVE CORPORATION
- Operator Number
- 9086399
- Address
- 8 KNIGHT STREET, Suite 201, --
- City
- Norwalk
- State
- CT
- Postal Code
- 06851
- Country
- US
- Correspondent
- Bradford - Siff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2021-07-12 |
Proprietary Names
BioWrap Electrode Garments
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device