| Device Type ID | 5177 |
| Device Name | Cable |
| Regulation Description | External Limb Prosthetic Component. |
| 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 | 890.3420 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ISN |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5177 |
| Device | Cable |
| Product Code | ISN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | External Limb Prosthetic Component. |
| CFR Regulation Number | 890.3420 [🔎] |
| Device Problems | |
|---|---|
Break | 8 |
Device Packaging Compromised | 7 |
Delivered As Unsterile Product | 6 |
Component Missing | 6 |
Unsealed Device Packaging | 5 |
Nonstandard Device | 5 |
Seal | 4 |
Cable | 4 |
Device Operates Differently Than Expected | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Packaging Problem | 3 |
Positioning Problem | 2 |
Material Integrity Problem | 2 |
Device Contamination With Body Fluid | 1 |
Catheter | 1 |
Device Displays Incorrect Message | 1 |
Contamination / Decontamination Problem | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 64 |