Changsha, CN · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQA | — | — | — | 2 | 2025-01-02 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Class II | Gastroenterology, Urology | 1 | 2026-05-14 |
| HIR | Perineometer | Class II | Obstetrics/Gynecology | 1 | 2026-04-27 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-14 | K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) | KPI | Class II | Gastroenterology, Urology |
| 2026-04-27 | K252748 | Pelvic Floor Exerciser (PF01) | HIR | Class II | Obstetrics/Gynecology |
| 2025-01-02 | K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | DQA | — | — |
| 2024-10-03 | K240808 | Pulse Oximeter (WS20A) | DQA | — | — |