| Device Type ID | 5164 |
| Device Name | Device, Warning, Overload, External Limb, Powered |
| Regulation Description | Powered External Limb Overload Warning Device. |
| 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 | 890.5575 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IRN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5164 |
| Device | Device, Warning, Overload, External Limb, Powered |
| Product Code | IRN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered External Limb Overload Warning Device. |
| CFR Regulation Number | 890.5575 [🔎] |