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510(k) Data Aggregation

    K Number
    K091933
    Device Name
    ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
    Manufacturer
    INNO-HEALTH TECHNOLOGY, INC.
    Date Cleared
    2010-04-02

    (276 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNO-HEALTH TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of ACULIFE/Model IDOC-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. ACULIFE/model IDOC-01 is intended for the stimulation at hands of patient.
    Device Description
    The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation.
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    K Number
    K051197
    Device Name
    ACULIFE, MODEL SMW-01
    Manufacturer
    INNO-HEALTH TECHNOLOGY, INC.
    Date Cleared
    2006-03-28

    (322 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNO-HEALTH TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.
    Device Description
    The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation. ACULIFE uses a 9V/DC battery or 9V adaptor as the supply power of the stimulation unit. It can be adjusted for the output amplitude, keep the memory of chosen amplitude, and set the operation time. The electrode combination and lead wire provide the electro-acupuncture stimulation for hand by or on the order of a qualified practitioner of acupuncture as determined by the states.
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