| Device Type ID | 2012 |
| Device Name | Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction |
| Regulation Description | Nonimplanted, Peripheral Electrical Continence Device. |
| 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 | 876.5310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NAM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2012 |
| Device | Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction |
| Product Code | NAM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonimplanted, Peripheral Electrical Continence Device. |
| CFR Regulation Number | 876.5310 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 75 |
Device Operates Differently Than Expected | 4 |
Failure To Deliver Energy | 2 |
Material Deformation | 1 |
Positioning Problem | 1 |
| Total Device Problems | 83 |