FDA Registration
Active
🇨🇳 China
Smart Neck Stimulator; 4098 (RED)
Reg #: 3014601569
·
FEI: 3014601569
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SKG Health Technologies Co., LTD
- Registration Number
- 3014601569
- FEI Number
- 3014601569
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 23A Floor,Building 3,Zhongke R & D Park,No. 009, Gaoxin South 1st Road,High-tech Zone Community,Yuehai str
- City
- Shen Zhen City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K200558
Owner / Operator
- Firm Name
- SKG Health Technologies Co., LTD
- Operator Number
- 10083283
- Address
- 23A Floor,Building 3,Zhongke R & D Park,No. 009, Gaoxin South 1st Road,High-tech Zone Community,Yuehai str She
- City
- Shen Zhen City
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- ZHIMIN LIN
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., Ltd
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301, Bellingham Barkley Villiage, WA
- City
- Bakerview
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-11-08 |
Proprietary Names
Smart Neck Stimulator; 4098 (RED)
Smart Neck Stimulator;G7ProE
Smart Neck Stimulator;4098E
Smart Neck Stimulator;K5-3EN
Smart Neck Stimulator;4356E
Smart Neck Stimulator;K5pro
Smart Neck Stimulator;K6E
Massager Neck Tens;1014706
Establishment Types
Manufacture Medical Device