| Device Type ID | 5151 |
| Device Name | Orthosis, Limb Brace |
| Regulation Description | Limb Orthosis. |
| 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 | 890.3475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IQI |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5151 |
| Device | Orthosis, Limb Brace |
| Product Code | IQI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Limb Orthosis. |
| CFR Regulation Number | 890.3475 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 37 |
Device Packaging Compromised | 3 |
Fungus In Device Environment | 3 |
Insufficient Information | 2 |
Gel Leak | 1 |
Material Rupture | 1 |
Patient Device Interaction Problem | 1 |
Failure To Obtain Sample | 1 |
Loss Of Or Failure To Bond | 1 |
Material Integrity Problem | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 53 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Mar-09-2018 |
| 2 | Breg Inc | II | Apr-10-2014 |
| 3 | DeRoyal Industries Inc | II | Dec-06-2016 |
| 4 | Ossur H / F | II | Mar-31-2016 |
| 5 | United Surgical Associates | II | May-23-2015 |