Zmi Electronics Ltd.
Kaohsiung, TW
ZMI ELECTRONICS LTD. appears in FDA device records in Kaohsiung, TW. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Zmi Electronics Ltd. between 2018 and 2025. The busiest year on record is 2018, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | KPI | Substantially Equivalent | |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | KPI | Substantially Equivalent | |
| K180865 | ZMI Self-Adhesive Electrodes | GXY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617486 | 1000442645 | ZMI ELECTRONICS LTD. | 6F-1, NO. 286-4, Shin Ya Rd., Chien Chen District,, KAOHSIUNG 806 TW | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GXYElectrode, Cutaneous
- ITHEquipment, Traction, Powered
- HLNGauge, Lens, Ophthalmic
- ILYLamp, Infrared, Therapeutic Heating
- OHSLight Based Over The Counter Wrinkle Reduction
- HIRPerineometer
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- GZIStimulator, Neuromuscular, External Functional
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain