Definition: Upper Extremity Prosthesis Intended To Replace Partially Or Fully Amputated Or Congenitally Absent Upper Extremities And To Provide Multiple And Simultaneous Degrees Of Freedom And Functionality.
| Device Type ID | 5237 |
| Device Name | Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography |
| Physical State | Upper Extremity Prosthesis Composed Of Plastic And Metal Materials With Electrodes And Circuitry. |
| Technical Method | Receives Multiple EMG Inputs From The User Which Is Transduced Into Multiple Dimensional Powered Joint Movements. |
| Target Area | Residual Portion Of Upper Extremity Limb Or An Absent Upper Extremity Limb. |
| Regulation Description | Upper Extremity Prosthesis Including A Simultaneously Powered Elbow And/or Shoulder With Greater Than Two Simultaneous Powered Degrees Of Freedom And Controlled By Non-implanted Electrical Components. |
| 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) |
| CFR Regulation Number | 890.3450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PAE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5237 |
| Device | Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography |
| Product Code | PAE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Upper Extremity Prosthesis Including A Simultaneously Powered Elbow And/or Shoulder With Greater Than Two Simultaneous Powered Degrees Of Freedom And Controlled By Non-implanted Electrical Components. |
| CFR Regulation Number | 890.3450 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEKA INTEGRATED SOLUTIONS CORPORATION | ||
GRANTED | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 3 |
Fracture | 2 |
Migration Or Expulsion Of Device | 2 |
Unstable | 1 |
Material Erosion | 1 |
| Total Device Problems | 9 |