| Device Type ID | 5129 |
| Device Name | Treadmill, 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 | IOL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5129 |
| Device | Treadmill, Powered |
| Product Code | IOL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Powered Exercise Equipment. |
| CFR Regulation Number | 890.5380 [🔎] |
| Device Problems | |
|---|---|
Calibration Error | 1 |
Break | 1 |
Device Operates Differently Than Expected | 1 |
Electrical /Electronic Property Problem | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AlterG, Incorporated | II | Mar-04-2014 |
| 2 | GE Healthcare | II | Jun-22-2015 |
| 3 | GE Healthcare | II | Mar-17-2015 |
| 4 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | II | Jul-16-2018 |