K213133 is an FDA 510(k) clearance for the Keffort (MC-100, MC-100A). This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by Oriental Inspiration Limited (Hong Kong, CN). The FDA issued a Cleared decision on April 13, 2022, 198 days after receiving the submission on September 27, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K213133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2021 |
| Decision Date | April 13, 2022 |
| Days to Decision | 198 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 |