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
Axiom	PXP1014PURIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1416F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1212BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP2121	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXPL1616	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS1414	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXPL1214	EUDAMEDFDA UDI	Class I	Active
Axiom One	XO2018	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1722V	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPB2018	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS1518	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1114BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	XS2219IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XASP1617	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPL1820	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP0908BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1522	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1418PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1011BLUIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1212BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP2118FIC	EUDAMED	Class I	Active
Lateral Trunk Pad	PLTASC4x5PP	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1011BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1715	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2217V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1720F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1109BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1615V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1415BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1822IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XS1417	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1616PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1614F	EUDAMEDFDA UDI	Class I	Active
Lateral Trunk Support	PLF3x4PL	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1720VIC	EUDAMED	Class I	Active
Axiom	XSP1719VIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1312PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	XG1414IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XP1619	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1517PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP0910BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1815	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1111BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	XS2016IC	EUDAMED	Class I	Active
Axiom	PXP1012BLUIC	EUDAMED	Class I	Active
Wheelchair back rest	PXAL1014	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1213BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPB1612	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1515BLKIC	EUDAMED	Class I	Active
Contour Positioning Pad	CP09SS	EUDAMEDFDA UDI	Class I	Active

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