FDA Registration
Active
🇨🇳 China
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04)
Reg #: 3026164517
·
FEI: 3026164517
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.
- Registration Number
- 3026164517
- FEI Number
- 3026164517
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Workshop 3 #, Shangyou Lefeng Technology Co., Ltd., Huangbu Industrial Park, Huangbu Town, Shangyou County
- City
- Ganzhou Jiangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230443
Owner / Operator
- Firm Name
- Jiangxi Royall Smart Technology Co., Ltd.
- Operator Number
- 10086681
- Address
- Workshop 3 #, Shangyou Lefeng Technology Co., Ltd., Huangbu Industrial Park, Huangbu Town, Shangyou County
- City
- Ganzhou
- State
- Jiangxi
- Postal Code
- 341200
- Country
- CN
- Correspondent
- Shunzhou Yang
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3357 158th St Flushing, NY
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2023-05-26 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2023-05-26 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2023-05-26 |
Proprietary Names
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04)
Establishment Types
Manufacture Medical Device