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Exerciser, Powered
FDA product code BXB · Class 1 · Physical Medicine
238
Registered devices
150
Adverse events
6
Recalls
160
510(k) clearances
Devices with this code
AlterG Anti-Gravity Treadmill — Lifeward CA, Inc.Medical HAL Lumbar Type — CYBERDYNE, INC.SafeGait 360 Balance and Mobility Trainer — DIH TECHNOLOGY INC.Lokomat — HOCOMA AGAlterG Anti-Gravity Treadmill — Lifeward CA, Inc.Lokomat — HOCOMA AGMedical HAL Lumbar Type — CYBERDYNE, INC.Handheld Direct Drive Cable Trainer — Beyond Power Inc.EN-Dynamic Rotator — Enraf-Nonius B.V.AlterG Anti-Gravity Treadmill — Lifeward CA, Inc.E-LINK DG1 Wireless Dongle — BIOMETRICS LIMITEDrebless — H ROBOTICS INC.EN-Dynamic Squat — Enraf-Nonius B.V.Lokomat — HOCOMA AGCHATTANOOGA — DJO, LLCHeaxel — HEALTH PIXEL SRLAPT Performer — COMPASS HEALTH BRANDS CORP.Lokomat — HOCOMA AGEN-Dynamic Adduction — Enraf-Nonius B.V.Revive 7200 — JK-Products GmbHAlterG Anti-Gravity Treadmill — Lifeward CA, Inc.E-LINK Software (Version 16) — BIOMETRICS LIMITEDHand of Hope — Rehab-Robotics Company LimitedEN-Dynamic Pull Down — Enraf-Nonius B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-01 | Btt Health Gmbh | Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart |
| 2019-07-29 | MOTEK MEDICAL B.V. | The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detachi |
| 2013-06-12 | Accelerated Care Plus Corporation | An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode. |
| 2012-11-12 | BioMotion Medical Systems, LLC | BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory d |
| 2011-07-15 | Alter-G, Incorporated | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. |
| 2009-05-27 | Hocoma AG | Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation |
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