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	PXSP1111BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2217F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2121F	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP0809PURIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1014PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPL1416	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1722	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1521F	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1010BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XASP1615	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXLB2010	EUDAMEDFDA UDI	Class I	Active
Axiom Posterior Back (PB)	AXPB1408	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1414PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	XG1620IC	EUDAMED	Class I	Active
Axiom	XS1622IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XAS1917	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1310BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXAL1216CL	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1518F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP0908PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXLB1818	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1412BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS1818	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1619	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1315BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1315BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1011PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1622	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1922	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1315BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1014BLKIC	EUDAMED	Class I	Active
Axiom	PXSP1113PURIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1010PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1414BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1721V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1419	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1518BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1110PURIC	EUDAMED	Class I	Active
Axiom PXP	PXP1415BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP0908BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1008PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPL1818	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXAL1414	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1419F	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXLB1420	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPB2012	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1417BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1519IC	EUDAMED	Class I	Active
Lateral Trunk Pad	PLF4x5PR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP2220	EUDAMEDFDA UDI	Class I	Active

KI MOBILITY, LLC

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