Definition: Non-measuring Exercise Equipment Intended For Medical Purposes Of Facilitating Stroke Rehabilitation And Maintaining Or Increasing Range Of Motion.
| Device Type ID | 5242 |
| Device Name | Exerciser, Non-measuring For Stroke Rehabilitation |
| Physical State | The Device May Consist Of Two Arm Frames Mechanically Linked That Allow The User To Use The Unaffected Arm To Move The Affect/weak Arm. The Device May Also Consist Of A Single Frame That Is Used By Both Upper Extremities Simultaneously With The Unaff |
| Technical Method | These Devices Are Not Powered Exercise Devices In That They Do Not Provide Movement To The User¿s Upper Limbs. The Movement Of The User's Upper Limbs Is Entirely Governed By The User. |
| Target Area | Upper Extremities |
| Regulation Description | Nonmeasuring Exercise Equipment. |
| 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 | 890.5370 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PKS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5242 |
| Device | Exerciser, Non-measuring For Stroke Rehabilitation |
| Product Code | PKS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonmeasuring Exercise Equipment. |
| CFR Regulation Number | 890.5370 [🔎] |