Definition: This Type Of Mechanical Walker Is A Four-legged Device With A Poly Vinyl Chloride (pvc) Frame Intended For Medical Purposes To Provide Moderate Weight Support While Walking. It Is Used By Disabled Persons Who Lack Strength, Good Balance, Or Endurance
| Device Type ID | 5230 |
| Device Name | Walker, Mechanical, Poly Vinyl Chloride (pvc) |
| Physical State | PVC |
| Technical Method | Class 1 (General Controls) |
| Target Area | Limbs |
| Regulation Description | Mechanical Walker. |
| 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 | 890.3825 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NXE |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5230 |
| Device | Walker, Mechanical, Poly Vinyl Chloride (pvc) |
| Product Code | NXE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Mechanical Walker. |
| CFR Regulation Number | 890.3825 [🔎] |