Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K081835
    Device Name
    ACTICARE IC AND TSE
    Manufacturer
    BIOINDUCTION LIMITED
    Date Cleared
    2009-03-19

    (265 days)

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

    BIOINDUCTION LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a Transcutaneous Electronic Nerve Stimulation (TENS) device for: the symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical or post-traumatic pain. As a Neuromuscular Electrostimulation (NMES) device for: the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis and to maintain or increase the range of motion.
    Device Description
    Acticare HFT/HFI is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves or muscles. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain or as a NMES device for muscle stimulation.
    Ask a Question

    Page 1 of 1