Definition: Used For Muscle Stimulation For Rehabilitation. Device Repeatedly Contracts Muscles By Passing Pulsed Electrical Current Through Cutaneous Electrodes Contacting The Affected Body Area. Indicated For Use As An Adjunctive Therapy In Rehabilitation For
| Device Type ID | 5231 |
| Device Name | Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation |
| Physical State | Electrical Stimulation Unit With Leads And Cutaneous Electrodes |
| Technical Method | Stimulation Of Muscles Using Electrical Current Applied To Electrodes On A Patient's Skin |
| Target Area | Electrodes Are Placed On The Skin Overlying The Muscle Or Motor Nerve To Be Stimulated |
| Regulation Description | Powered Muscle Stimulator. |
| 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 | 890.5850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NYY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5231 |
| Device | Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation |
| Product Code | NYY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Muscle Stimulator. |
| CFR Regulation Number | 890.5850 [🔎] |