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U.S. Department of Health and Human Services

Product Classification

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Device cpr aid device without feedback
Regulation Description Cardiopulmonary resuscitation (CPR) aid.
Definition A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the cpr being provided.These devices are intended for use by persons professionally trained in cpr to assure proper use and the delivery of optimal cpr to the victim.
Physical State External device that provides audio and/or visual prompting of rate and/or ventilation and/or proper placement of hands for CPR, in accordance with current CPR Guidelines.
Technical Method mechanical, electro-mechanical, software can be included. Prompting only - no real-time feedback related to the CPR being performed.
Target Area Near rescuer (non patient contact) on chest - skin contact.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePMK
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 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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