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	XSP1617F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1614BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1916FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1210BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXLB1616	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1821IC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP0810BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1615PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2016V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XG1620	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1616BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1013BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1515BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1318BLKIC	EUDAMED	Class I	Active
Wheelchair back rest	AXPB1818	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XG1414	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS1418	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1615	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1922IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XS1820	EUDAMEDFDA UDI	Class I	Active
Lateral Pad	PBLF4X5PR	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXAL1618	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1822F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1615BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP0810BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1918F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP0910PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1618FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XS1619	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1419VIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XG1617	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1514PURIC	EUDAMED	Class I	Active
Wheelchair bracket	TS14MA	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1920IC	EUDAMED	Class I	Active
Wheelchair back rest	AXPL1616	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP0810PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	XP1516IC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1113PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXAL1614CL	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS1821	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1314PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1916IC	EUDAMED	Class I	Active
Axiom	PXP1212BLUIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1815F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1919	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPB1808	EUDAMEDFDA UDI	Class I	Active
Axiom	XP2019IC	EUDAMED	Class I	Active
Wheelchair back rest	AXPB1814	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1617	EUDAMEDFDA UDI	Class I	Active
Wheelchair bracket	CP10PL	EUDAMEDFDA UDI	Class I	Active

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