Definition: Provides A Counter-pressure To The Anus During Vaginal Delivery. Intended To Prevent The Occurrence Of And/or Stop The Progression Of Hemorrhoids Associated With Vaginal Delivery.
| Device Type ID | 4069 |
| Device Name | Hemorrhoid Prevention Pressure Wedge |
| Physical State | Items Include: Rigid Base With Cushioning Pad And Two Lateral Straps And Two Adhesive Pads That Are Applied To The Buttocks |
| Technical Method | Uses A Rigid Base With Cushioning Pad Applied To The Anus Held In Place By Two Adhesive Strips Attached To The Buttocks, To Provide A Counter-pressure To The Anus During Vaginal Delivery |
| Target Area | Anus, Hemorrhoids |
| Regulation Description | Hemorrhoid Prevention Pressure Wedge. |
| 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 | 884.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OOA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4069 |
| Device | Hemorrhoid Prevention Pressure Wedge |
| Product Code | OOA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemorrhoid Prevention Pressure Wedge. |
| CFR Regulation Number | 884.5200 [🔎] |