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	PXP1013BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1411BLUIC	EUDAMED	Class I	Active
Axiom	XSP1521FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP2019V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1513BLK	EUDAMEDFDA UDI	Class I	Active
Lateral Pad	PLLS3X4PL	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2218V	EUDAMEDFDA UDI	Class I	Active
Lateral Trunk Pad	PLTAS4x5PR	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXLB1612	EUDAMEDFDA UDI	Class I	Active
Lateral Trunk Pad	PLTAS3x4PR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1014BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP2119	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1316BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XG2221	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2216F	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1518BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XAS1822	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS2220	EUDAMEDFDA UDI	Class I	Active
Axiom Lateral Back (LB)	AXLB2210	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1820	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1720	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XG1619	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1718	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPB1212	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1514BLKIC	EUDAMED	Class I	Active
Wheelchair/chair/stander occupant restraint/support	14851	EUDAMEDFDA UDI	Class I	Active
Axiom	XP1917IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XAS1816	EUDAMEDFDA UDI	Class I	Active
Wheelchair bracket	PBLAS3X4PP	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1418PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1112PURIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP2118F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS2222	EUDAMEDFDA UDI	Class I	Active
Axiom	XG2019IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XAS1821	EUDAMEDFDA UDI	Class I	Active
Wheelchair bracket	PLLS4x5PP	EUDAMEDFDA UDI	Class I	Active
Wheelchair bracket	CP10MA	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1318BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPL1812	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXPL1808	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1414BLU	EUDAMEDFDA UDI	Class I	Active
Lateral Trunk Pad	PLTAS3x4PP	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1717F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1014BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1112BLK	EUDAMEDFDA UDI	Class I	Active
Axiom ASP	Axiom ASP	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1009BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XG1921	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1014BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1916	EUDAMEDFDA UDI	Class I	Active

KI MOBILITY, LLC

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