510(k) Report

FDA applicant

Hoveround Corp.

Sarasota, FL17 decisions1994–20131 recall

FDA records 17 decisions for Hoveround Corp. (Sarasota, FL) from 1994 to 2013: 17 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and ILK (Transport, Patient, Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Hoveround Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2009: 12010: 32013: 2
2007high 3 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hoveround Corp.’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?

  • ITIWheelchair, Powered15decisions
  • ILKTransport, Patient, Powered1decision
  • INIVehicle, Motorized 3-Wheeled1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K935410Hoveround MPVHoveround Corp. · 19941cites it
  • K090108Hoveround Teknique FWD MK4 Power WheelchairHoveround Corp. · 20091cites it

What has FDA decided for it lately?

  • K122707Hoverround TekniqueHoveround Corp. · 2013
  • K122741Hoveround TekniqueHoveround Corp. · 2013
  • K100527Hoveround Teknique, Model HD-6Hoveround Corp. · 2010
  • K093946Hoveround Hoverglide Model Hoverglide MK-2Hoveround Corp. · 2010
  • K100350Hoveround Teknique GT Power Wheelchair, Model# Teknique GTHoveround Corp. · 2010
  • K090108Hoveround Teknique FWD MK4 Power WheelchairHoveround Corp. · 2009
  • K043069Hoveround E100 Power ChairHoveround Corp. · 2004
  • K042920Hoveround SE-3 PowerchairHoveround Corp. · 20041 recall

All 17 as Hoveround Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042920ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of…Oct 17, 2005