FDA Registration
Active
🇹🇼 Taiwan
ZMI ELECTRONICS LTD.
Reg #: 9617486
·
FEI: 1000442645
·
Expires 2026
Products
14
Proprietary Names
28
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- ZMI ELECTRONICS LTD.
- Registration Number
- 9617486
- FEI Number
- 1000442645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F-1, NO. 286-4, Shin Ya Rd., Chien Chen District,
- City
- KAOHSIUNG
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K220997
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 |
|---|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2020-12-01 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2018-02-08 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2023-03-02 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2023-03-02 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2018-08-13 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2008-10-08 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2008-10-08 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2008-10-08 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2025-04-22 |
| Equipment, Traction, Powered | ITH | Class 2 | Physical Medicine | No | 2009-10-27 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 2019-03-27 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2016-10-05 |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | Class 2 | Physical Medicine | No | 2008-10-08 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2024-02-15 |
Proprietary Names
Carewear Firefly Wrinkle Reduction
PowerDot(R) PD-01M Muscle Stimulator (with PowerDot (R) Mobile Application)
Levina JointVive series Electrode Set
NeuroMD RS-18 Wireless Muscle Stimulator
Levina RS-38 Menstrual Pain Relief Stimulator
Levina Magnetic PADS
Levina RS-18 Wireless TENS/EMS Stimulator
JointVive Wireless TENS/EMS STIMULATOR by Levina
ZMI Self-Adhesive Electrodes
IR THERAPY PAD LGT-200LED
PowerDot(R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application)
Omnistim FX2 Portable
Omnistim 500
Omnistim 500B
Omnistim 500C Pro
Levina Pelvic Floor Muscle Stimulator
MTD 4000
Omnistim FX2 Pro Sport
Omnistim Sport Elite
Omnistim FX2 Pro
Omnistim FX2
PowerDot(R) PD-01M2 Muscle Stimulator (with PowerDot (R) Mobile Application)
PowerDot(R) PD-01MT Muscle Stimulator (with PowerDot (R) Mobile Application)
WalkAide System
Carewear CWC-1
Neuroprobe 500
Omnisound 3000E
Levina Pelvic Floor Probe
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device