Question 1

What types of medical devices does KI Mobility, LLC primarily manufacture?

Accepted Answer

KI Mobility, LLC specializes in wheelchair-related products, including air-filled chair cushions for seating comfort, prefabricated head and trunk supports, adjustable backrests for both manual and electric wheelchairs, and battery-powered reclining mechanisms. Their offerings also include push-rim manual wheelchairs designed for non-bariatric users and specialized seating accessories like viscoelastic cushion covers and pelvic support systems. These devices focus on improving stability, comfort, and mobility for wheelchair users.

Question 2

Where is KI Mobility, LLC based, and in which markets do their devices operate?

Accepted Answer

KI Mobility, LLC is based in the United States. Their devices are intended for use in both the U.S. and European markets, where they are registered in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. This reflects compliance with relevant regulatory requirements in those regions.

Question 3

How are KI Mobility, LLC’s devices classified under medical device regulations?

Accepted Answer

KI Mobility, LLC’s devices are classified under Class I and Class II regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and patient population.

Question 4

Which regulatory registries list KI Mobility, LLC’s devices?

Accepted Answer

KI Mobility, LLC’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system, which tracks devices marketed in the United States. These listings help ensure transparency and traceability of their products in both markets.

Question 5

Why do some of KI Mobility, LLC’s devices fall under different regulatory classes?

Accepted Answer

The classification of medical devices depends on their intended use, potential risks, and the body part or system they interact with. For example, air-filled cushions (like the *Cover Inco Axiom SP Visco*) are typically Class I because they pose low risk, while wheelchair recliners (like the *Star* series) may be Class II due to their mechanical complexity and the need for additional safety controls. The FDA and EU regulations categorize devices based on these factors to determine oversight requirements.

Device	Model / Reference	Registries	Class	Status
Wheelchair seat cushion	XASP1916	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1920V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1822V	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1517PURIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1013BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP2221	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1616FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XG1821	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1617	EUDAMEDFDA UDI	Class I	Active
Upper Extremity Support Tray	125277	EUDAMED	Class I	Active
Wheelchair back rest	AXLB1220	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1109BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS2220	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1615BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XG1416	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPL1816	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP0809BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1415PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1513BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1215BLUIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1112PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS2218	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS2121	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1012PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS2021	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP0809BLK	EUDAMEDFDA UDI	Class I	Active
Lateral Trunk Pad	PLF4x5PL	EUDAMEDFDA UDI	Class I	Active
Axiom	XS2218IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XAS1819	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2119F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1518BLK	EUDAMEDFDA UDI	Class I	Active
Axiom G	Axiom G	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1414PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1310PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1921V	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXAL1012CL	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PLF4x5P	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1514BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1615BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1414BLUIC	EUDAMED	Class I	Active
Wheelchair back rest	AXPB1610	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS2122	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1517V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1519	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPB2214	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1011BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1514BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPB1208	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1619FIC	EUDAMED	Class I	Active
Axiom PXP	PXP0909BLK	EUDAMEDFDA UDI	Class I	Active

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