Definition: Vibrator For Climax Control Training For The Treatment Of Premature Ejaculation.
| Device Type ID | 2095 |
| Device Name | Vibrator For Climax Control Of Premature Ejaculation |
| Physical State | The Device Consists Of A Vibrator Connected To A Battery Pack. |
| Technical Method | Battery-operated Vibrator And Lubricant For Climax Control Of Premature Ejaculation For Men |
| Target Area | Male Genitals |
| Regulation Description | Vibrator For Climax Control Of Premature Ejaculation. |
| 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) Exempt |
| CFR Regulation Number | 876.5025 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2095 |
| Device | Vibrator For Climax Control Of Premature Ejaculation |
| Product Code | PIA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vibrator For Climax Control Of Premature Ejaculation. |
| CFR Regulation Number | 876.5025 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ERGON MEDICAL LTD. | ||
GRANTED | 1 | |