| Device Type ID | 5056 |
| Device Name | Exerciser, Powered |
| Regulation Description | Powered 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 | 890.5380 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BXB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5056 |
| Device | Exerciser, Powered |
| Product Code | BXB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Powered Exercise Equipment. |
| CFR Regulation Number | 890.5380 [🔎] |
| Device Problems | |
|---|---|
Mechanics Altered | 4 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Use Of Device Problem | 2 |
Labelling, Instructions For Use Or Training Problem | 1 |
| Total Device Problems | 9 |