8 results
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12ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·January 15, 2014
Karma Flexx Wheelchair Manual Wheelchair.
FDA Enforcement
Class II
·Terminated·Karman Healthcare Inc·March 9, 2016
TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.
FDA Enforcement
Class II
·Terminated·TiSport, Llc·August 28, 2019
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
FDA Enforcement
Class II
·Terminated·Pdg Product Design Group Inc·October 1, 2014
Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.
FDA Enforcement
Class II
·Terminated·The Standing Company·February 26, 2014
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·February 13, 2013
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·August 8, 2012
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·December 12, 2018