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ActiveStep
SIMBEX LLC · Model 008-B GS Edition · UDI-DI 00860003532003
10
510(k) clearances
153
Adverse events (1 deaths)
19
Recalls
25
Facilities
Description
The ActiveStep is an instrumented treadmill for pre-emptive rehabilitation, gait analysis and research. The ActiveStep system consists of a powered treadmill; harness and support structure; Intertial Measurement Unit (IMU) and computer for control and data acquisition.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-12 | Full Vision Inc | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| 2023-05-12 | Full Vision Inc | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| 2023-05-12 | Full Vision Inc | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| 2023-05-12 | Full Vision Inc | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| 2023-05-12 | Full Vision Inc | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| 2023-05-12 | Full Vision Inc | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| 2023-05-12 | Full Vision Inc | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| 2022-08-31 | Full Vision Inc | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnet |
| 2022-08-31 | Full Vision Inc | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnet |
| 2022-08-31 | Full Vision Inc | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnet |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.