510(k) Report

FDA applicant

Care Rehab and Orthopaedic

Mclean, VA3 decisions2002–20030 recalls

FDA records 3 decisions for Care Rehab and Orthopaedic (Mclean, VA) from 2002 to 2003: 3 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 2 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 Care Rehab and Orthopaedic’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Care Rehab and Orthopaedic since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Care Rehab and Orthopaedic 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?

  • IPFStimulator, Muscle, Powered2decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K023036Care EtsCare Rehab and Orthopaedic · 2003
  • K022417Care StimCare Rehab and Orthopaedic · 2003
  • K020637Select StimCare Rehab and Orthopaedic · 2002

All 3 as Care Rehab and Orthopaedic →