510(k) Report

FDA applicant

Ki Mobility, LLC

Stevens Point, WI5 decisions2006–20230 recalls

FDA records 5 decisions for Ki Mobility, LLC (Stevens Point, WI) from 2006 to 2023: 5 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and LBE (Stroller, Adaptive). Since 2016 its 510(k)s took a median of 1,155 days from receipt to decision, against 61 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Ki Mobility, LLC’s devices, and how often a recall has named them.

FDA decisions per year

4in 2023

2023: 4
2007high 4 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ki Mobility, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ki Mobility, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IORWheelchair, Mechanical3decisions
  • LBEStroller, Adaptive1decision
  • ITIWheelchair, Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 1,155 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 61 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223527Little Wave Clik, Rogue XP, Little Wave XP, SparkKi Mobility, LLC · 20232cite it
  • K062660CatalysyKi Mobility, LLC · 20061cites it

What has FDA decided for it lately?

  • K201869Ki Power Tilt SystemKi Mobility, LLC · 2023
  • K200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLKi Mobility, LLC · 2023
  • K223527Little Wave Clik, Rogue XP, Little Wave XP, SparkKi Mobility, LLC · 2023
  • K223533Little Wave Arc; Little Wave FlipKi Mobility, LLC · 2023
  • K062660CatalysyKi Mobility, LLC · 2006

All 5 as Ki Mobility, LLC →