Definition: To Provide Rehabilitation (e.G., Increasing Range Of Motion, Muscle Re-education) Through Emg-triggered Powered Exercise. Increasing Range Of Motion And Muscle Re-education.
| Device Type ID | 5233 |
| Device Name | Exercise Equipment, Powered, Emg-triggered |
| Physical State | EMG Sensor, Plus Other Apparatus Such As A DC Motor, Limb Orthosis, And Connecting Cables Through Which Tension Is Applied. |
| Technical Method | EMG In Affected Area Is Sensed, Processed, And Used As An Input To Control A DC Motor Or Other Actuator That Applies A Force/torque To Move An Affected Joint Through Range Of Motion. |
| Target Area | Typically, Such A Device Will Be Used On The Upper Extremity Or Possibily The Lower Extremity. |
| Regulation Description | Diagnostic Electromyograph. |
| 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 | 890.1375 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5233 |
| Device | Exercise Equipment, Powered, Emg-triggered |
| Product Code | OAL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Electromyograph. |
| CFR Regulation Number | 890.1375 [🔎] |