510(k) Report

FDA applicant

Neuromusclar Electrical Stimulation Systems, Ltd.

Washington, DC2 decisions1996–20010 recalls

FDA records 2 decisions for Neuromusclar Electrical Stimulation Systems, Ltd. (Washington, DC) from 1996 to 2001: 2 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GZI (Stimulator, Neuromuscular, External Functional). Its devices cite 3 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 Neuromusclar Electrical Stimulation Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neuromusclar Electrical Stimulation Systems, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neuromusclar Electrical Stimulation Systems, Ltd. 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, Powered1decision
  • GZIStimulator, Neuromuscular, External Functional1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K952273Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 19964cite it
  • K010837HandmasterNeuromusclar Electrical Stimulation Systems, Ltd. · 20012cite it

What has FDA decided for it lately?

  • K010837HandmasterNeuromusclar Electrical Stimulation Systems, Ltd. · 2001
  • K952273Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 1996

All 2 as Neuromusclar Electrical Stimulation Systems, Ltd. →