DEN170049 is an FDA 510(k) submission for the Innovo. This device is classified as a Cutaneous Electrode Stimulator For Urinary Incontinence (Class II - Special Controls, product code QAJ).
Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Not Cleared (DENG) decision on November 6, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5330. A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence..
| 510(k) Number | DEN170049 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 18, 2017 |
| Decision Date | November 06, 2018 |
| Days to Decision | 414 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | QAJ — Cutaneous Electrode Stimulator For Urinary Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5330 |
| Definition | A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence. |