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EnsoETM

Advanced Cooling Therapy, LLC · Model ECD01-A · UDI-DI 00857915006166

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.

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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.