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Ovation 400

ARETECH, LLC · Model OV-400 · UDI-DI 00850018836029

BXB

510(k) clearances

151

Adverse events

Recalls

116

Facilities

Description

The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.

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 of the medical devic
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 detaching from the cable gu
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 deficiencies involvin
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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Data 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.