510(k) Report

FDA applicant

Tzora Active Systems, Ltd.

Kibbutz Tzora, IL5 decisions2001–20180 recalls

FDA records 5 decisions for Tzora Active Systems, Ltd. (Kibbutz Tzora, IL) from 2001 to 2018: 5 510(k) clearances. All are in product code INI (Vehicle, Motorized 3-Wheeled). Its devices cite 3 predicates, 3 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 Tzora Active Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12017: 12018: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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