510(k) Report

FDA applicant

Alfa Tech Medical Systems, Ltd.

Great Neck, NY2 decisions2005–20070 recalls

FDA records 2 decisions for Alfa Tech Medical Systems, Ltd. (Great Neck, NY) from 2005 to 2007: 2 510(k) clearances. All are in product code IMG (Stimulator, Ultrasound And Muscle, For Use In…). Its devices cite 3 predicates, 1 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 Alfa Tech Medical Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alfa Tech Medical 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?

  • IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K052340DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemAlfa Tech Medical Systems, Ltd. · 20052cite it

What has FDA decided for it lately?

  • K063728TNN-DU810 Non-Invasive Subdermal Therapy SystemAlfa Tech Medical Systems, Ltd. · 2007
  • K052340DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemAlfa Tech Medical Systems, Ltd. · 2005

All 2 as Alfa Tech Medical Systems, Ltd. →

Other applicant names beginning “Alfa”

FDA records each applicant name separately; these may or may not be the same firm.

Alfa Scientific Designs, Inc. 44Alfa Wassermann Diagnostic Technologies, Inc. 23Alfa Wassermann, Inc. 9Alfa Biotech (Uk), Ltd. 3Alfa Wassermann Diagnostics Technologies, LLC 3Alfa Technologies, Inc. 1Alfa Thermodiagnostics, Inc. 1Alfa Gate Mazen, Ltd. 1