FDA Registration
Active
🇺🇸 United States
ELECTRONIC WAVEFORM LAB, INC.
Reg #: 2023152
·
FEI: 2023152
·
Expires 2026
Products
6
Proprietary Names
2
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ELECTRONIC WAVEFORM LAB, INC.
- Registration Number
- 2023152
- FEI Number
- 2023152
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5702 Bolsa Ave
- City
- Huntingtn Bch
- State
- CA
- ZIP
- 92649
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160255
Owner / Operator
- Firm Name
- ELECTRONIC WAVEFORM LABORATORY, INC.
- Operator Number
- 2023152
- Address
- 5702 Bolsa Ave, --
- City
- Huntington Beach
- State
- CA
- Postal Code
- 92649
- Country
- US
- Correspondent
- W. J HEANEY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2017-11-09 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2017-11-09 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2017-11-09 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2008-01-03 |
| Device, Electrical Dental Anesthesia | LWM | Class U | Unknown | No | 2008-01-03 |
| Device, Muscle Monitoring | KZM | Class 2 | Physical Medicine | No | 2008-01-03 |
Proprietary Names
H-Wave OTC
H-Wave
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility