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510(k) Data Aggregation

    K Number
    K000741
    Device Name
    EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188
    Manufacturer
    138 MEDICAL SUPPLIES, INC.
    Date Cleared
    2001-10-24

    (596 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    138 MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K992709
    Device Name
    1818 TENS UNIT
    Manufacturer
    138 MEDICAL SUPPLIES, INC.
    Date Cleared
    1999-11-09

    (90 days)

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

    138 MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
    Device Description
    The device is used to transmit electrical pulses through the skin to the underlying peripheral nerves to help in the blockage of the pain signal traveling to the brain.
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