K222528 is an FDA 510(k) clearance for the Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode. This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by Well-Life Healthcare Limited (New Taipei City, TW). The FDA issued a Cleared decision on December 29, 2022, 129 days after receiving the submission on August 22, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K222528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2022 |
| Decision Date | December 29, 2022 |
| Days to Decision | 129 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 |