K241899 is an FDA 510(k) clearance for the Pelvic Floor Stimulator (Intrelief PFE), a Stimulator, Electrical, Non-implantable, For Incontinence (Class II — Special Controls, product code KPI), submitted by Easymed Instruments Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on November 27, 2024, 152 days after receiving the submission on June 28, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K241899 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 28, 2024 |
| Decision Date | November 27, 2024 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KPI — Stimulator, Electrical, Non-implantable, For Incontinence |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5320 |