FDA Registration
Active
🇨🇳 China
Epulse Ultra 1420
Reg #: 3010402752
·
FEI: 3010402752
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
- Registration Number
- 3010402752
- FEI Number
- 3010402752
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2F, Yongcheng Blvd, Xicheng Industrial Zone, Xixiang Street, Bao'an District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233092
Owner / Operator
- Firm Name
- Hong Qiangxing (Shen Zhen) Electronics Limited
- Operator Number
- 10044280
- Address
- 2F, Yongcheng Blvd, Xicheng Industrial Zone, Xixiang Street, Bao'an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518126
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2024-04-15 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2024-04-15 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2024-04-15 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2024-04-15 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2024-04-15 |
Proprietary Names
Epulse Ultra 1420
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)