FDA Registration
Active
🇨🇳 China
HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD
Reg #: 3010417025
·
FEI: 3010417025
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD
- Registration Number
- 3010417025
- FEI Number
- 3010417025
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building D17/22, Baiyan Science & Technology Industrial Park, No.168 XiangZhang Road,
- City
- Hefei Anhui
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K190617
Owner / Operator
- Firm Name
- HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD
- Operator Number
- 10044091
- Address
- Building D17/22, Baiyan Science & Techno, No.168 XiangZhang Road,
- City
- Hefei
- State
- Anhui
- Postal Code
- 230088
- Country
- CN
- Correspondent
- Eric Chen
US Agent
- Business Name
- Hi-Dow International Incorporated
- Contact Name
- Eric Chen
- Address
- 2555 Metro Blvd.
- City
- Maryland Heights
- State
- MO
- ZIP
- 63043
- Country
- US
- [email protected]
- Phone
- 314 5692888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2019-08-07 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2021-11-01 |
| Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | ILX | Class 2 | Physical Medicine | No | 2021-11-01 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2017-12-09 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2017-12-09 |
Proprietary Names
Wrap Accessory Electrodes
Pulsed Electromagnetic Field Wrap
HIDOW Wireless TENS/EMS
Hi-Dow Pro Touch Wireless 6-12 (HD-19A)
Hidow TENS/EMS
Establishment Types
Manufacture Medical Device