| Device Type ID | 1971 |
| Device Name | Stimulator, Electrical, Non-implantable, For Incontinence |
| Regulation Description | Nonimplanted 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 | 876.5320 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KPI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1971 |
| Device | Stimulator, Electrical, Non-implantable, For Incontinence |
| Product Code | KPI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonimplanted Electrical Continence Device. |
| CFR Regulation Number | 876.5320 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FUJI DYNAMICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INCONTROL MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 4 | |
INTERNATIONAL TRADE GROUP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TENSCARE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
| Total Device Problems | 1 |