FDA Registration
Active
🇨🇳 China
Compex Performance 3
Reg #: 3010770433
·
FEI: 3010770433
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- EBULENT OPTRONICS (SHENZHEN) LTD
- Registration Number
- 3010770433
- FEI Number
- 3010770433
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Block901, Floor9, Building 1, Senyang Electronics Technologies Park, Guangming District, Shenzhen, Guangdong
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201653
Owner / Operator
- Firm Name
- Ebulent Optronics (Shenzhen) LTD
- Operator Number
- 10061444
- Address
- Block A&B, Floor 9, Building 1, Senyang Electronics Technologies Park, Guangming District, Shenzhen, Guangdong
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518107
- Country
- CN
- Correspondent
- Ansen Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2020-12-01 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2020-12-01 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2020-12-01 |
Proprietary Names
Compex Performance 3
Compex Sport Elite 3
Compex Edge 3
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)