| Device Type ID | 5174 |
| Device Name | Component, External, Limb, Ankle/foot |
| 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 | ISH |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5174 |
| Device | Component, External, Limb, Ankle/foot |
| Product Code | ISH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | External Limb Prosthetic Component. |
| CFR Regulation Number | 890.3420 [🔎] |
| Device Problems | |
|---|---|
Fracture | 8 |
Component Incompatible | 2 |
Detachment Of Device Component | 1 |
Device-Device Incompatibility | 1 |
Break | 1 |
Defective Device | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 15 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ossur Americas, Inc. | II | Feb-06-2014 |
| 2 | Ossur H / F | II | Mar-17-2015 |
| 3 | Otto Bock Healthcare GmbH | II | Nov-04-2015 |