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Exerciser, Powered
FDA product code BXB · Class 1 · Physical Medicine
246
Registered devices
151
Adverse events
6
Recalls
160
510(k) clearances
Devices with this code
Active Passive Trainer For Upper And Lower Limbs — Guangzhou Pinzhi Medical Technology Co., LTDRed Wave Recovery — JK-Products GmbHOmniCycle® Revo — medica - Medizintechnik GmbHAPT PERFORMER — Drive Devilbiss HealthcareLokomat — HOCOMA AGHeaxel — HEALTH PIXEL SRLAlterG Anti-Gravity Treadmill — Lifeward CA, Inc.Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape — JK-Products GmbHSwimEx Aquatherapy pool — SwimEx, Inc.CHATTANOOGA — DJO, LLCHandheld Direct Drive Cable Trainer — Beyond Power Inc.AlterG Anti-Gravity Treadmill — Lifeward CA, Inc.Erigo — HOCOMA AGOMEGO — tyromotion GmbHEN-Dynamic Triceps Dips — Enraf-Nonius B.V.RL-500 — DAESUNG MAREF CO.,LTD.APT PERFORMER — Drive Devilbiss HealthcareRL-500 — DAESUNG MAREF CO.,LTD.Biodex — SPORT MEDICAL TECHNOLOGY INC.AlterG Anti-Gravity Treadmill — Lifeward CA, Inc.rebless — H ROBOTICS INC.Vector Gait and Safety System — Bioness Medical, Inc.AlterG Anti-Gravity Treadmill — Lifeward CA, Inc.AMADEO — tyromotion GmbH
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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