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U.S. Department of Health and Human Services

Product Classification

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Device piezo-electric stimulator for relief of mosquito bite itch
Definition Relief / Reduction of Mosquito Bite Itch
Physical State The device is hand-held, composed of an insulated housing which contains a piezo-electric crystal and conductive elements to deliver charge to the skin, as well as a moving mechanical part to allow the intended user to generate the force to produce the electrical charge.
Technical Method Electrical charge, generated via piezo-electric crystal, delivered transcutaneously at the site of the mosquito bite. The piezo-electric crystal generates electrical charge by the application of a manual mechanical force.
Target Area Intended to be placed on the skin, at the site of a mosquito bite.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOSG
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(K) Exempt
Regulation Number 882.5894
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    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 exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures 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 requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible