Definition: Aid For Drop Foot Or Similar Disorders Which Have A Lack Of Ankle Dorsiflexion. Indicated For Foot Raising Paresis.
| Device Type ID | 5234 |
| Device Name | Orthosis, Foot Drop |
| Physical State | Includes Shoulder Harness, Optional Waist Belt, Optional Shoulder Pad, An Elastic Cord Assembly And A Shoe Harness |
| Technical Method | Uses An Elastic Cord From Shoulder Harness To Foot To Provide Foot Raising Support |
| Target Area | Intended To Help Raise Foot |
| Regulation Description | Limb Orthosis. |
| 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 | 890.3475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OHI |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5234 |
| Device | Orthosis, Foot Drop |
| Product Code | OHI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Limb Orthosis. |
| CFR Regulation Number | 890.3475 [🔎] |