Shenzhen, CN · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Class II | Gastroenterology, Urology | 3 | 2026-06-18 |
| IPF | Stimulator, Muscle, Powered | Class II | Physical Medicine | 1 | 2020-12-08 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-18 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) | KPI | Class II | Gastroenterology, Urology |
| 2024-02-23 | K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | KPI | Class II | Gastroenterology, Urology |
| 2022-07-20 | K220161 | Biofeedback Nerve and Muscle Stimulator | KPI | Class II | Gastroenterology, Urology |
| 2020-12-08 | K202648 | Biofeedback Nerve and Muscle Stimulator | IPF | Class II | Physical Medicine |