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Axiom Air LTE
KI MOBILITY, LLC · Model XLTE1616 · UDI-DI 00840363305769
10
510(k) clearances
172
Adverse events (4 deaths)
1
Recalls
130
Facilities
Description
Air-filled, adjustable cushion designed for use with wheelchairs. Cushion with standard cover.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-20 | Roho Inc. | When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitt |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.