Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Ki Mobility with 5 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Sep 5, 2023: Ki Power Tilt System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 5, 2023 | Ki Power Tilt SystemK201869 · ITI | 510(k) clearances |
| Sep 5, 2023 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLK200583 · IOR | 510(k) clearances |
| Aug 31, 2023 | Little Wave Arc; Little Wave FlipK223533 · LBE | 510(k) clearances |
| Aug 31, 2023 | Little Wave Clik, Rogue XP, Little Wave XP, SparkK223527 · IOR | 510(k) clearances |
| Nov 19, 2021 | Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be uClass III · The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not | Device recalls |
| Oct 24, 2006 | CATALYSYK062660 · IOR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
