510(k) Report

FDA applicant

Independence Technology, LLC

Somerville2 decisions2003–20033 recalls

FDA records 2 decisions for Independence Technology, LLC (Somerville) in 2003: 1 510(k) clearance and 1 original PMA approval. Most are in product codes IMK (Wheelchair, Stair Climbing) and ITI (Wheelchair, Powered). 3 recalls are 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 Independence Technology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Independence Technology, LLC since 2007.

Recalls per year

1in 2010

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

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • IMKWheelchair, Stair Climbing1decision
  • ITIWheelchair, Powered1decision

What has FDA decided for it lately?

  • P020033Independence (TM) Ibot 3000/4000 Mobility SystemIndependence Technology, LLC · 20033 recalls
  • K030250Iglide Manual Assist WheelchairIndependence Technology, LLC · 2003

All 2 as Independence Technology, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • P020033iBOT 4000 Mobility System Battery pack.Feb 22, 2010
  • P020033iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing…Aug 30, 2004
  • P020033iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing…Jul 1, 2004