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Toe Clip PPG Sensor

VIASONIX LTD · Model Toe Clip PPG Sensor · UDI-DI 07290016880168

JOP Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The Toe Clip PPG sensor is designed in shape as a clothespin, primarily to fit comfortably to the toes. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests

Recalls

Date	Firm	Reason
2014-06-26	Biosound Esaote, Inc.	Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.