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Sign in to claim this brandKI MOBILITY, LLC
United States·US-MF-000012633
Last updated May 25, 2026
What KI MOBILITY, LLC makes
KI Mobility, LLC manufactures air-filled cushioning systems for seating, including prefabricated head and trunk supports for wheelchairs, as well as adjustable backrests for manual and electric wheelchairs. Their product line also includes battery-powered reclining mechanisms for wheelchairs and push-rim manual wheelchairs designed for non-bariatric use. The company produces viscoelastic cushion covers and specialized pelvic support systems for improved seating stability and comfort.
The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These products are intended for use in both European and U.S. markets, adhering to applicable medical device directives and registration requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does KI Mobility, LLC primarily manufacture?
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.
Where is KI Mobility, LLC based, and in which markets do their devices operate?
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.
How are KI Mobility, LLC’s devices classified under medical device regulations?
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.
Which regulatory registries list KI Mobility, LLC’s devices?
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.
Why do some of KI Mobility, LLC’s devices fall under different regulatory classes?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5201, Woodward Dr, Stevens Point, United States
- Website
- www.kimobility.com
- —
- —
- [email protected]
- Phone
- +1 715 303 6447
- PRRC Contact
- Giovanny Espinosa
- EUDAMED SRN
- US-MF-000012633
- FDA FEI Number
- —
- DUNS Number
- 609305656
Catalogue (1847)
Page 1 of 37| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anterior Pelvic Support | 126437 | EUDAMED | Class I | Active |
| Cover Inco Axiom SP Visco | XSPC1720VINCO | EUDAMED | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Spark | SPARK | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Axiom | DL | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Standard Air | FDA UDI | Class I | Active |
| Star | Stabil Air | FDA UDI | Class I | Active |
| Axiom | Lateral Trunk Supports | FDA UDI | Class I | Active |
| Star | Star Lock | FDA UDI | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
KI Mobility, LLC has one recall record initiated on November 19, 2021. The recall was terminated, and the reason stated was that the Instructions for Use for the device were intended for a mechanical wheelchair rather than a chair with casters.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 19, 2021 | Z-0467-2022 | — | terminated | The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. |