Definition: Applying Compression To The Muscles Of The Foot For The Purpose Of Affecting Nerve Impulses Sent To The Central Nervous System.
| Device Type ID | 3822 |
| Device Name | Foot Wrap For Treating Restless Leg Syndrome Symptoms |
| Physical State | Compressive Wrap. |
| Technical Method | Applies Pressure To The Abductor Hallucis And Abductor Hallucis Brevis Adequate To Affect The Peripheral Nervous System. |
| Target Area | Abductor Hallucis And Abductor Hallucis Brevis Muscles. |
| Regulation Description | Nonpowered Lower Extremity Pressure Wrap. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Neurology |
| 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 | 890.5760 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OTX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3822 |
| Device | Foot Wrap For Treating Restless Leg Syndrome Symptoms |
| Product Code | OTX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpowered Lower Extremity Pressure Wrap. |
| CFR Regulation Number | 890.5760 [🔎] |