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    K Number
    K172971
    Device Name
    BMLS16-1
    Manufacturer
    BioMedical Life Systems, Inc.
    Date Cleared
    2018-07-08

    (285 days)

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

    BioMedical Life Systems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BMLS16-1 Transcutaneous Electrical Nerve Stimulation (TENS) device is used for the symptomatic relief and management of chronic (long-term) intractable pain.
    Device Description
    Transcutaneous Electrical Nerve Stimulator For Pain Relief
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    K Number
    K102051
    Device Name
    PAIN BUDDY
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2011-07-29

    (373 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    Not Found
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    K Number
    K061476
    Device Name
    ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2006-07-26

    (57 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electrical Nerve Stimulation (TENS) devices are used 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
    Not Found
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    K Number
    K042711
    Device Name
    MODEL BMLS03-7
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2005-03-14

    (165 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (TENS) Transcutaneous Electrical Nerve Stimulator Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used 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. Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: relaxation of muscle spasm; muscle reeducation; prevention of disuse atrophy; maintaining and increasing the range of motion; and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. High Volt Pulsed Current Stimulator Mode: High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of muscle of disuse atrophy, relaxation of muscle spasm, muscle reeducation, maintaining and increasing the range of motion, and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7
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    K Number
    K041388
    Device Name
    COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-11-23

    (182 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. TENS Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1
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    K Number
    K040007
    Device Name
    INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-07-07

    (187 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or intractable pain and as an adjunct in the management of post-surgical and post-traumatic acute pain.
    Device Description
    Interferential Stimulator Model BMLS02-6
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    K Number
    K033174
    Device Name
    BMLS03-3
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-06-30

    (273 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    The BMLS03-3 is a portable, battery-powered four channel neuromuscular stimulator. The output waveform can be set to symmetrical or asymmetrical biphasic rectangular. The pulse rate range is 1-120 Hz. The pulse width range is 50-400 microseconds. The output intensity range is 0-100 milliamps. It can be set to constant, cycled, or reciprocating modes, and has several preprogrammed modes. All device functions and status are displayed on a graphic LCD.
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    K Number
    K040824
    Device Name
    INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-04-29

    (30 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
    Device Description
    Interferential Stimulator Model BMLS03-6
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    K Number
    K040306
    Device Name
    HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-03-23

    (43 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    High Volt Pulsed Current Stimulator For Muscle Reeducation - Class II Model BMLS02-7
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    K Number
    K033455
    Device Name
    ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-01-15

    (77 days)

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

    BIOMEDICAL LIFE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electrical Nerve Stimulation (TENS) devices are used 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
    (TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS03-5
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