FDA applicant

ZetrOZ Systems, LLC

Trumbull, CT5 decisions2020–20260 recalls

FDA records 5 decisions for ZetrOZ Systems, LLC (Trumbull, CT) from 2020 to 2026: 5 510(k) clearances. All are in product code PFW (Stationary Ultrasonic Diathermy Device For Use…). Its devices cite 5 predicates, 4 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 ZetrOZ Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020high 2 (2023) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — ZetrOZ Systems, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like ZetrOZ Systems, LLC’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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Other applicant names beginning “ZetrOZ”

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

Zetroz, Inc. 1

ZetrOZ Systems, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “ZetrOZ”