| Device Type ID | 5181 |
| Device Name | Assembly, Knee/shank/ankle/foot, External |
| Regulation Description | External Assembled Lower Limb Prosthesis. |
| 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 | 890.3500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ISW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5181 |
| Device | Assembly, Knee/shank/ankle/foot, External |
| Product Code | ISW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Assembled Lower Limb Prosthesis. |
| CFR Regulation Number | 890.3500 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 9 |
Solder Joint Fracture | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Electrical /Electronic Property Problem | 1 |
Inadequate Service | 1 |
Battery Problem | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Material Fragmentation | 1 |
Human Factors Issue | 1 |
Material Protrusion / Extrusion | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ability Dynamics LLC | II | Jun-18-2014 |
| 2 | Ossur H / F | II | Mar-25-2015 |
| 3 | Otto Bock Healthcare Product | II | Aug-21-2015 |