Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040580
    Device Name
    AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
    Date Cleared
    2004-08-26

    (175 days)

    Product Code
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    NRW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DY Instrument, Inc. AIS100 Automatic Intramuscular Stimulator Device is intended, as part of a treatment regimen, for 1. Intramuscular stimulation 2. Symptomatic relief of tension-type headache of myofascial origin
    Device Description
    The AIS 100 is an intramuscular stimulator device that aids administering of intramuscular stimulation (or dry needling) for treatment. The device produces an automated forward and backward motion of a needle at a constant speed, which replaces the manual stroking of a needle when rendering the intramuscular stimulation (or dry needling) treatment. This enables the practitioner to administer the intramuscular stimulation treatment effectively with less physical effort when compared to the manual method. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1