Definition: A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence.
| Device Type ID | 2160 |
| Device Name | Cutaneous Electrode Stimulator For Urinary Incontinence |
| Physical State | Electrodes |
| Technical Method | Current Applied To Pelvic Floor Muscles To Improve Strength. |
| Target Area | Pelvic Floor Muscles |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2160 |
| Device | Cutaneous Electrode Stimulator For Urinary Incontinence |
| Product Code | QAJ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 876.5330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIO-MEDICAL RESEARCH LTD. | ||
GRANTED | 1 | |