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KARMA MOBILITY COMPANY LIMITED · Model Flexx Junior · UDI-DI 04719873857395

IOR

510(k) clearances

31,335

Adverse events (55 deaths)

Recalls

133

Facilities

Description

The Flexx Junior is a pediatric manual wheelchair designed to provide mobility, comfort, and postural support for children with mobility limitations. Available in self-propelled (Model FLX-J00 with fixed backrest, Model FLX-J50 with foldable backrest) and transit configurations, it is primarily intended for indoor use with limited outdoor capability on smooth surfaces. The wheelchair offers both self-propulsion with 20" or 22" quick-release rear wheels and transit propulsion with 14" quick-release rear wheels. The device supports users weighing up to (165 lbs) 75 kg and is engineered for growth and incorporates adjustable features to accommodate growth.

Recalls

Date	Firm	Reason
2021-09-24	TiSport, Llc	Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if inv
2018-09-11	TiSport, Llc	The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.
2016-07-01	Sunrise Medical (US) LLC	There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causin
2016-01-27	Karman Healthcare Inc	Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
2015-07-27	Sunrise Medical (US) LLC	Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
2015-07-27	Sunrise Medical (US) LLC	Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
2014-12-19	Sunrise Medical (US) LLC	There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
2014-12-19	Sunrise Medical (US) LLC	There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
2014-10-10	Silver Star Brands	Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels..
2013-11-11	Sunrise Medical (US) LLC	There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base.

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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.