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 back rest	AXPL1216	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1214BLK	EUDAMEDFDA UDI	Class I	Active
Lateral Pad	PLTASC4x5PR	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1920FIC	EUDAMED	Class I	Active
Wheelchair back rest	AXPL1622	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1516FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1517F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1719	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1417	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1514BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1722F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1614	EUDAMEDFDA UDI	Class I	Active
Axiom PXP	PXP1318PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP0910BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1011BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1919VIC	EUDAMED	Class I	Active
Axiom	PXP1112BLKIC	EUDAMED	Class I	Active
Axiom	XSP1614VIC	EUDAMED	Class I	Active
Axiom	PXP1318BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XASP1818	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS2022	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1013BLKIC	EUDAMED	Class I	Active
Axiom	PXSP1311BLUIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1518PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XG1517	EUDAMEDFDA UDI	Class I	Active
Axiom	XP1622IC	EUDAMED	Class I	Active
Wheelchair back rest	AXPL1220	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS1920	EUDAMEDFDA UDI	Class I	Active
Rogue XP	ROGUE XP	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1412BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1619IC	EUDAMED	Class I	Active
Wheelchair/chair/stander occupant restraint/support	14942	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1009BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XP1920	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1921IC	EUDAMED	Class I	Active
Axiom	XP1416IC	EUDAMED	Class I	Active
Axiom	XSP1821FIC	EUDAMED	Class I	Active
Air LTE	XLTE1816	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS2018	EUDAMEDFDA UDI	Class I	Active
Wheelchair bracket	CS08PL	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1514BLUIC	EUDAMED	Class I	Active
Axiom LB	Axiom LB	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP0810BLUIC	EUDAMED	Class I	Active
Axiom	XSP2120VIC	EUDAMED	Class I	Active
Axiom	PXP1211BLUIC	EUDAMED	Class I	Active

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