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  2. Wearable cardioverter defibrillator - Wikipedia

    en.wikipedia.org/wiki/Wearable_cardioverter...

    The WCD was extensively tested for three years in 17 major medical centers across the United States and Europe. The clinical data collected from those trials [26] allowed Lifecor to obtain FDA approval for use of the WCD in the United States. [citation needed] In 2001, the FDA approved the LifeVest wearable cardioverter defibrillator (model 2000).

  3. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    [1] [2] The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford. [3] The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt. [4]

  4. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration

  5. Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Code_of_Federal_Regulations

    In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation.

  6. Medical device design - Wikipedia

    en.wikipedia.org/wiki/Medical_device_design

    The FDA then requires these devices to undergo stringent clinical reviews. [5] For these reviews, the FDA require some type of clinical evidence or trials. [5] If the sponsor believes the device is low to moderate risk, the sponsor may apply to change this default classification. [5] The FDA, upon review may then reclassify these devices as de ...

  7. Police vehicles equipped with automated external ...

    en.wikipedia.org/wiki/Police_Vehicles_Equipped...

    A defibrillator in every active patrol vehicle [17] 2007: N/A: N/A: N/A Florida: Lakeland Police Department: 131 defibrillators distributed among marked police vehicles [18] N/A: N/A: N/A: The funds for the defibrillators were raised through donations by members of the public. Between 400 and 500 people donated money which totaled $122,500. [18 ...

  8. Automated external defibrillator - Wikipedia

    en.wikipedia.org/wiki/Automated_external...

    An automated external defibrillator or automatic electronic defibrillator (AED) is a portable electronic device that automatically diagnoses the life-threatening cardiac arrhythmias of ventricular fibrillation (VF) and pulseless ventricular tachycardia, [1] and is able to treat them through defibrillation, the application of electricity which stops the arrhythmia, allowing the heart to re ...

  9. Emergency medical responder levels by U.S. state - Wikipedia

    en.wikipedia.org/wiki/Emergency_medical...

    As of 2011, 38 states use the NREMT examination for EMT certification and 45 states use the NREMT examination for Paramedic certification. [3] These levels are denoted below using an asterisk (*). At present time, use of the NREMT examination for EMT-Intermediate 85 and 99 have not been included in this list.