FDA Registration
Active
🇨🇳 China
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
Reg #: 3012729332
·
FEI: 3012729332
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GUANGZHOU HUAKAI ELECTRONIC TECHNOLOGY CO., LTD.
- Registration Number
- 3012729332
- FEI Number
- 3012729332
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4th Floor, Building 8, Bigang Ind Zone, Nangang,Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221251
Owner / Operator
- Firm Name
- Guangzhou HuaKai Electronic Technology Co., Ltd.
- Operator Number
- 10050595
- Address
- 4th Floor, Building 8, Bigang Ind Zone, Nangang,Huangpu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510730
- Country
- CN
- Correspondent
- Anna Wu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-08-29 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-08-29 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2022-08-29 |
Proprietary Names
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
Establishment Types
Manufacture Medical Device