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	XSP1519V	EUDAMEDFDA UDI	Class I	Active
Wheelchair/chair/stander occupant restraint/support	14858	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1109BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair/chair/stander occupant restraint/support	14259	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2220F	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1513PURIC	EUDAMED	Class I	Active
Wheelchair back rest	AXPL1620	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1310BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1615BLK	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1721FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1617PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1315PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1620	EUDAMEDFDA UDI	Class I	Active
Axiom One	XO2220	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1109BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2222V	EUDAMEDFDA UDI	Class I	Active
Axiom	XG1716IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XG1621	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1719FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1517PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1315BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1214PURIC	EUDAMED	Class I	Active
Wheelchair back rest	PXAL1214	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1922F	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1415IC	EUDAMED	Class I	Active
Wheelchair/chair/stander occupant restraint/support	14283	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP2118	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1518PURIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1622V	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP2017VIC	EUDAMED	Class I	Active
Lateral Trunk Pad	PLF4x5PP	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1011BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1416BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XAS1922	EUDAMEDFDA UDI	Class I	Active
Wheelchair bracket	CS14SS	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PXPL1614	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1411BLU	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1717FIC	EUDAMED	Class I	Active
Axiom SPV	Axiom SPV	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XG1719	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1316BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1818	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1618BLUIC	EUDAMED	Class I	Active
Axiom	PXP1414BLUIC	EUDAMED	Class I	Active
Axiom	XSP2221FIC	EUDAMED	Class I	Active
Wheelchair back rest	AXPL2010	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1114PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1518BLUIC	EUDAMED	Class I	Active
Axiom	XSP1922VIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXSP1311BLU	EUDAMEDFDA UDI	Class I	Active

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