510(k) Report

FDA applicant

Lifewatch Technologies, Ltd.

Rehovot, IL4 decisions2014–20160 recalls

FDA records 4 decisions for Lifewatch Technologies, Ltd. (Rehovot, IL) from 2014 to 2016: 4 510(k) clearances. All are in product code DSI (Detector And Alarm, Arrhythmia). Its devices cite 6 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, cardiovascular panel, where it files most

How often FDA has decided Lifewatch Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2014: 12015: 12016: 2
2014high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Lifewatch Technologies, Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Lifewatch”

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