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510(k) Data Aggregation

    K Number
    K990233
    Device Name
    ST-302 INFRAREX
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1999-10-27

    (275 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INFRAREX temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
    Device Description
    Not Found
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    K Number
    K984506
    Device Name
    SD-100 SKYEAR THERMOMETER
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1999-07-29

    (223 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SD-100 SKYEAR THERMOMETER is designed for file 3D 100 -
    Device Description
    Not Found
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    K Number
    K981449
    Device Name
    SD-956 ULTRASOUND THERAPY
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1998-12-11

    (233 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SD-956 generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
    Device Description
    SD-956 Ultrasound Therapy
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    K Number
    K983964
    Device Name
    BATCH #6060 CONDUCTIVE GEL
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1998-12-09

    (33 days)

    Product Code
    GYB, IKC
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.
    Device Description
    BATCH #6060 CONDUCTIVE GEL
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    K Number
    K964437
    Device Name
    GB-1002 TENS WITH MASSAGE
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1998-08-14

    (647 days)

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

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DE VICES ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (I ONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS. A THERAPEUTIC VIBRATOR IS INTENDED FOR RELAXING MUSCLES AND RELIEVING MINOR MUSCLE ACTIES AND PAINS.
    Device Description
    GB-1002 TENS WITH VIBRATOR
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    K Number
    K974585
    Device Name
    IF-727 INTERFERENTIAL STIMULATOR
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1998-03-06

    (88 days)

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

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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
    K964434
    Device Name
    SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1997-10-09

    (338 days)

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

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 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.
    Device Description
    SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
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    K Number
    K963729
    Device Name
    SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1997-02-13

    (150 days)

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

    SKYLARK DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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