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U.S. Department of Health and Human Services

Product Classification

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Device cpr aid feedback device (no software)
Regulation Description Cardiopulmonary resuscitation (CPR) aid.
Definition Provides real-time feedback to the rescuer regarding the quality of cpr being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual cpr in accordance with current accepted cpr guidelines.
Physical State An external device generally placed on or near the subject/victim and provides audio and/or visual feedback to the rescuer.
Technical Method Mechanical or electro-mechanical. No software.
Target Area Chest - skin contact.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePMJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(K) Exempt
Regulation Number 870.5210
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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