Definition: Rectal Or Vaginal Use Manual Therapeutic Massager Device To Massage Irritable, Sore Trigger Points (trps) In The Pelvic Floor Musculature In Order To Reduce Internal Pelvic Floor Trigger Point Sensitivity
| Device Type ID | 5236 |
| Device Name | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature |
| Physical State | An Extended Shaft Witha Hook-shaped End And A Handle And A Gauge That Measures Pressure Of Massage |
| Technical Method | Manual Massage |
| Target Area | Pelvic Floor Musculature |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5670 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5236 |
| Device | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature |
| Product Code | OSD |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 890.5670 [🔎] |