510(k) Report

FDA applicant

Lorenz Biotech S.P.A.

North Attleboro, MA2 decisions2007–20080 recalls

FDA records 2 decisions for Lorenz Biotech S.P.A. (North Attleboro, MA) from 2007 to 2008: 2 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 12 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 Lorenz Biotech S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lorenz Biotech S.P.A. 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?

  • GXYElectrode, Cutaneous1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

Whose devices does it build on?

Its devices cite 12 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K080902Frems SSC Disposable Foam Electrodes, Model 800-000-057; Frems SSC Disposable Non-Woven Electrodes, Model…Lorenz Biotech S.P.A. · 2008
  • K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007

All 2 as Lorenz Biotech S.P.A. →

Other applicant names beginning “Lorenz”

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

Lorenz Instruments 1