| Device Type ID | 2164 |
| Device Name | Perineometer |
| Regulation Description | Perineometer. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.1425 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HIR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2164 |
| Device | Perineometer |
| Product Code | HIR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Perineometer. |
| CFR Regulation Number | 884.1425 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED TACTILE IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANALYTICA LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOINFINITY (M)SDN.BHD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RALSTON GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REGULATORY INSIGHT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REMENDIUM LABS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |