K230767 is an FDA 510(k) clearance for the Pelvic Floor Muscle Stimulator. This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by Nanjing Vishee Medical Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 21, 2023, 185 days after receiving the submission on March 20, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K230767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2023 |
| Decision Date | September 21, 2023 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPI - Stimulator, Electrical, Non-implantable, For Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5320 |