Lite— 510(k) K172409

Substantially Equivalent

Tzora Active Systems , Ltd.

FDA 510(k) clearance K172409 for Lite, Substantially Equivalent on 2018-05-02. Applicant: Tzora Active Systems , Ltd..

Clearance details

Applicant: Tzora Active Systems , Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2017-08-09
Decision date: 2018-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kibbutz Tzora, IL

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.