510(k) Report

FDA applicant

R82 A/S

Stallings, NC5 decisions2003–20160 recalls

FDA records 5 decisions for R82 A/S (Stallings, NC) from 2003 to 2016: 5 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and IPL (Wheelchair, Standup). 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 R82 A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010: 12016: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R82 A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IORWheelchair, Mechanical4decisions
  • IPLWheelchair, Standup1decision

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.

  • K151492KuduR82 A/S · 20162cite it
  • K100084Multi Frame WheelchairR82 A/S · 20101cites it

What has FDA decided for it lately?

  • K151492KuduR82 A/S · 2016
  • K100084Multi Frame WheelchairR82 A/S · 2010
  • K061810Cougar WheelchairR82 A/S · 2006
  • K033460Cheetah WheelchairR82 A/S · 2004
  • K030882Rabbit Mobile Standing FrameR82 A/S · 2003

All 5 as R82 A/S →