Data / Medical devices / United States / Ki Mobility
Ki Mobility: FDA-registered device maker in Stevens Point, WI, United States, 6 510(k) clearances
Ki Mobility is registered with the FDA (registration 3005905321) in Stevens Point, WI, United States. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 10, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005905321
- Address
- 5201 Woodward DR, Stevens Point, WI, United States, 54481
- Owner or operator
- Ki Mobility (10023866)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 18, 2007
- Registered through
- 2026
- Brand names listed
- Axiom AS, Axiom ASP, Axiom Air LTE, Axiom Back AXDL, Axiom Back AXLB, Axiom Back AXPB, Axiom Back AXPL, Axiom Custom Back AXCB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stroller, Adaptive | LBE | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 10, 2025 | K240267 | Klaxon (Twist); Klaxon (Twist R) | ITI | Substantially Equivalent | Klaxon Mobility GmbH | accessdata.fda.gov |
| September 5, 2023 | K201869 | Ki Power Tilt System | ITI | Substantially Equivalent | Ki Mobility, LLC | accessdata.fda.gov |
| September 5, 2023 | K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | IOR | Substantially Equivalent | Ki Mobility, LLC | accessdata.fda.gov |
| August 31, 2023 | K223533 | Little Wave Arc; Little Wave Flip | LBE | Substantially Equivalent | Ki Mobility, LLC | accessdata.fda.gov |
| August 31, 2023 | K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | IOR | Substantially Equivalent | Ki Mobility, LLC | accessdata.fda.gov |
| October 24, 2006 | K062660 | CATALYSY | IOR | Substantially Equivalent | Ki Mobility, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 19, 2021 | 89204 | Class III | Terminated | Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one | The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. | accessdata.fda.gov |
Compare with other makers
- All makers of Cushion, Wheelchair
- All makers of Accessories, Wheelchair
- All makers of Stroller, Adaptive
- All makers of Wheelchair, Mechanical
- All makers of Cushion, Flotation
- All makers of Chair, With Casters
Updated January 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.