510(k) Report

FDA applicant

Newcare Products, LLC

Rockville, MD1 decision2002–20020 recalls

FDA records 1 decision for Newcare Products, LLC (Rockville, MD) in 2002: 1 510(k) clearance. All are in product code 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, neurology panel, where it files most

How often FDA has decided Newcare Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Newcare Products, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Newcare Products, LLC 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?

  • 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:

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.

  • K013167MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 20023cite it

What has FDA decided for it lately?

  • K013167MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002

The one decision as Newcare Products, LLC →