| Device Type ID | 5140 |
| Device Name | Crutch |
| Regulation Description | Crutch. |
| 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 | 890.3150 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IPR |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5140 |
| Device | Crutch |
| Product Code | IPR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Crutch. |
| CFR Regulation Number | 890.3150 [🔎] |
| Device Problems | |
|---|---|
Break | 6 |
Disassembly | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Material Integrity Problem | 2 |
Fracture | 2 |
Device Operates Differently Than Expected | 2 |
Material Twisted / Bent | 1 |
Bent | 1 |
Unstable | 1 |
Collapse | 1 |
Device Slipped | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Material Deformation | 1 |
Out-Of-Box Failure | 1 |
Device Issue | 1 |
| Total Device Problems | 27 |