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	XSP1920F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1919	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1013PURIC	EUDAMED	Class I	Active
Lateral Pad	PBLAS3X4PL	EUDAMEDFDA UDI	Class I	Active
Air LTE	XLTE1618	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	PLTAS3x4P	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1917	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP2016	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP1919	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1818V	EUDAMEDFDA UDI	Class I	Active
Upper Extremity Support Tray	125278	EUDAMED	Class I	Active
Axiom	XP1720IC	EUDAMED	Class I	Active
Axiom PXP	PXP1517BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1010PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	XSP1519FIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XP1917	EUDAMEDFDA UDI	Class I	Active
Axiom	PXP1008BLUIC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1519F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP2122	EUDAMEDFDA UDI	Class I	Active
Lateral Pelvic Pad	PLPF4x5PP	EUDAMEDFDA UDI	Class I	Active
Wheelchair bracket	TS14SS	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1718F	EUDAMEDFDA UDI	Class I	Active
Axiom	PXSP1314BLKIC	EUDAMED	Class I	Active
Wheelchair seat cushion	PXP1211PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP0808BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1114BLK	EUDAMEDFDA UDI	Class I	Active
Wheelchair back rest	AXLB2022	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XASP1420	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XP2018	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XS1416	EUDAMEDFDA UDI	Class I	Active
Axiom	XP1518IC	EUDAMED	Class I	Active
Wheelchair back rest	AXPL1420	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1212PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS1918	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXSP1109PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XAS2120	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1310BLU	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1515F	EUDAMEDFDA UDI	Class I	Active
Axiom	XS2019IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XAS1920	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP2120V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1216PUR	EUDAMEDFDA UDI	Class I	Active
Axiom	XS1615IC	EUDAMED	Class I	Active
Wheelchair seat cushion	XSP1817F	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XG1716	EUDAMEDFDA UDI	Class I	Active
Axiom PXP	PXP1008BLU	EUDAMEDFDA UDI	Class I	Active
Lateral Trunk Support	PLTAS3x4PL	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1819V	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	PXP1114PUR	EUDAMEDFDA UDI	Class I	Active
Wheelchair seat cushion	XSP1815V	EUDAMEDFDA UDI	Class I	Active

KI MOBILITY, LLC

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