| Device Type ID | 5141 |
| Device Name | Cane |
| Regulation Description | Cane. |
| 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 | 890.3075 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IPS |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5141 |
| Device | Cane |
| Product Code | IPS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cane. |
| CFR Regulation Number | 890.3075 [🔎] |
| Device Problems | |
|---|---|
Break | 25 |
Fracture | 20 |
Unstable | 7 |
Bent | 6 |
Product Quality Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Detachment Of Device Component | 4 |
Collapse | 3 |
Crack | 3 |
Component(s), Broken | 2 |
Material Integrity Problem | 2 |
Defective Component | 1 |
Material Twisted / Bent | 1 |
Use Of Device Problem | 1 |
Device Tipped Over | 1 |
Mechanical Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Fitting Problem | 1 |
Material Fragmentation | 1 |
Out-Of-Box Failure | 1 |
Material Protrusion / Extrusion | 1 |
| Total Device Problems | 91 |