Exerciser, Powered

Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

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 of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).

Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indi

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.

SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen t

BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involving the former owners of the SpineSix product and concurrently preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix.

AlterG Anti-Gravity Treadmill;

Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.

Hocoma Lokomat-System with Pediatric Module

Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation

Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of su

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 detaching from the cable guide.