510(k) Report

FDA applicant

Durable Medical Equipment, Inc.

Pittsboro, NC2 decisions1993–20020 recalls

FDA records 2 decisions for Durable Medical Equipment, Inc. (Pittsboro, NC) from 1993 to 2002: 2 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and ITI (Wheelchair, Powered). Its devices cite 1 predicate, 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 Durable Medical Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Durable Medical Equipment, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Durable Medical Equipment, Inc.’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?

  • IORWheelchair, Mechanical1decision
  • ITIWheelchair, Powered1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K013361Win-2 Tango Elite NPDurable Medical Equipment, Inc. · 2002
  • K934297Durable Medical Equipment Company, Standard Mechanical WheelchairDurable Medical Equipment, Inc. · 1993

All 2 as Durable Medical Equipment, Inc. →