BEUDAMED
    Product Code: OSG FDA class 2 21 CFR 882.5894

    Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

    Neurology

    The Piezo-Electric Stimulator for Relief of Mosquito Bite Itch (product code OSG) is a small consumer device that uses piezo-electric technology to deliver a brief electrical stimulus to the skin at the site of a mosquito bite, providing relief or reduction of itching. It works by modifying the local nerve response to histamine-induced itch. As an FDA Class 2 device under regulation 882.5894, it requires 510(k) premarket clearance and falls within the Neurology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    2
    Years Active
    0

    Basic Information

    Product Code
    OSG
    Device Class
    FDA class 2
    Regulation Number
    882.5894
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Relief / Reduction of Mosquito Bite Itch

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    DEN130019 ZANZA-CLICK
    DEN100024 ZAP-IT!

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.