General Information About the Regulatory Status of HemaShock®
HemaShock® is intended for use in patients whose systolic blood pressure is pathologically low (i.e. less than 80 mm Hg in adults) due to Hemodynamic Shock or Circulatory (Cardiac) Arrest. HemaShock® shares technology with the Surgical Exsanguination Tourniquet manufactured by OHK as HemaClear® (www.HemaClear.com) which has been cleared for use in many countries around the world. The following is information on the regulatory status of the device in various countries. Should you have any questions, please contact us.
The device is classified as Class I, based on Annex IX, Rule 4 of the Medical Directive 93/42/EEC.
The Surgical Exsanguination Tourniquet was cleared by the FDA in 2002. The HemaShock® FDA clearance needs a further submission.