| Device Type ID | 3961 |
| Device Name | Heater, Perineal, Direct Contact |
| Regulation Description | Perineal Heater. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| 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) Exempt |
| CFR Regulation Number | 884.5390 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HGZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3961 |
| Device | Heater, Perineal, Direct Contact |
| Product Code | HGZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Perineal Heater. |
| CFR Regulation Number | 884.5390 [🔎] |