510(k) Report

FDA applicant

Digitimer, Ltd.

Fort Lauderdale, FL2 decisions2005–20180 recalls

FDA records 2 decisions for Digitimer, Ltd. (Fort Lauderdale, FL) from 2005 to 2018: 2 510(k) clearances. Most are in product codes GWF (Stimulator, Electrical, Evoked Response) and IPF (Stimulator, Muscle, Powered). 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 Digitimer, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Digitimer, Ltd.’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?

  • GWFStimulator, Electrical, Evoked Response1decision
  • IPFStimulator, Muscle, Powered1decision

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 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.

  • K051357DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator…Digitimer, Ltd. · 20055cite it
  • K172381Digitimer DS7AP Constant Current StimulatorDigitimer, Ltd. · 20181cites it

What has FDA decided for it lately?

  • K172381Digitimer DS7AP Constant Current StimulatorDigitimer, Ltd. · 2018
  • K051357DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator…Digitimer, Ltd. · 2005

All 2 as Digitimer, Ltd. →