510(k) Report

FDA applicant

Care Rehab, Inc.

Mclean, VA4 decisions1999–20020 recalls

FDA records 4 decisions for Care Rehab, Inc. (Mclean, VA) from 1999 to 2002: 4 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and IPF (Stimulator, Muscle, Powered). Its devices cite 4 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, neurology panel, where it files most

How often FDA has decided Care Rehab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Care Rehab, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Care Rehab, Inc.’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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief2decisions
  • IPFStimulator, Muscle, Powered1decision
  • LIHInterferential Current Therapy1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K020437Classic TensCare Rehab, Inc. · 20022cite it
  • K021905Classic NMSCare Rehab, Inc. · 20021cites it

What has FDA decided for it lately?

  • K021905Classic NMSCare Rehab, Inc. · 2002
  • K020516Care Ifc PlusCare Rehab, Inc. · 2002
  • K020437Classic TensCare Rehab, Inc. · 2002
  • K984025Care TensCare Rehab, Inc. · 1999

All 4 as Care Rehab, Inc. →