FDA Registration
Active
🇹🇼 Taiwan
PowerDot(R) PD-01M2 Muscle Stimulator (with PowerDot (R) Mobile Application)
Reg #: 9617486
·
FEI: 1000442645
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ZMI ELECTRONICS LTD.
- Registration Number
- 9617486
- FEI Number
- 1000442645
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6F-1, NO. 286-4, Shin Ya Rd., Chien Chen District,
- City
- KAOHSIUNG
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K210938
Owner / Operator
- Firm Name
- ZMI ELECTRONICS, LTD.
- Operator Number
- 9035676
- Address
- 6F-1, NO. 286-4, SHIN YA RD, --
- City
- KAOHSIUNG
- State
- TW-NOTA
- Postal Code
- 806
- Country
- TW
- Correspondent
- YUTA - LEE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-08-09 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2021-08-09 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 2019-03-27 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-08-09 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2021-08-09 |
Proprietary Names
PowerDot(R) PD-01M2 Muscle Stimulator (with PowerDot (R) Mobile Application)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)