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510(k) Data Aggregation

    K Number
    K993229
    Device Name
    ANALGESIC PULSER, MODEL AP-439
    Manufacturer
    JOHARI ELECTRO-TECH CO.
    Date Cleared
    2001-02-02

    (494 days)

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

    JOHARI ELECTRO-TECH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for: 1. Symptomatic relief and management of chronic (long term) intractable pain. 2. Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions. (B) Electrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for: 1. Relaxation of Muscle spasm. 2. Prevention or Retardation of disuse atrophy. 3. Increasing local blood circulation. 4. Muscle re-education. 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6. Maintaining or increasing range of motion. ( C) Galvanic-DC Continuous mode is indicated for :- 1. Relaxation of muscle spasm.
    Device Description
    ANALGESIC PULSER AP-439 is an electrical nerve muscle stimulator with two outputs and four channels. It offers various waveforms including Monophasic, Biphasic, Sinewave & D.C. Line. It has different modes of stimulation such as Faradic, Interferential, DC continuous, and DC Interrupted, with specified maximum output current and voltage for each. It also provides different modulation options for amplitude and frequency.
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