LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133789
    Device Name
    DOLPHIN NEUROSTIM OTC
    Manufacturer
    ACUMED MEDICAL LTD.
    Date Cleared
    2015-03-04

    (447 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMED MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin Neurostim™ OT C is indicated for temporary relief of pain associated with sore and aching muscles in the back, arms, and legs due to strain from exercise or normal household and work activities.
    Device Description
    The Dolphin Neurostim™ OTC (DNS) is a handheld, battery powered (9V) Transcutaneous Electrical Nerve Stimulators (TENS), specifically designed for the temporary relief of muscular pain. It combines the electrical characteristics of TENS with point stimulation delivered through a metal probe tip (cathode or anode). There is a metal ground on the device and an ancillary wrist strap that plugs into the device (cathode or anode). The device has two modes of operation. In search mode it locates points of low resistance in a predetermined area. In treatment mode it applies a low-frequency (2.4-3.0 Hz) Direct Current to the skin.
    Ask a Question

    Page 1 of 1