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510(k) Data Aggregation

    K Number
    K053007
    Device Name
    SKYLARK URO PROBE
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2005-12-05

    (40 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SKYLARK DEVICE **& SYSTEMS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.
    Device Description
    Not Found
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    K Number
    K050174
    Device Name
    BIO-STIM KIT
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2005-09-07

    (225 days)

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

    **SKYLARK DEVICE **& SYSTEMS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.
    Device Description
    Not Found
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    K Number
    K043306
    Device Name
    SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2005-06-06

    (187 days)

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

    **SKYLARK DEVICE **& SYSTEMS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.
    Device Description
    Skylark Infrared Lamp, Models SD-956IR and SD-100IR
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    K Number
    K034005
    Device Name
    SDS-4I
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2004-11-18

    (330 days)

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

    **SKYLARK DEVICE **& SYSTEMS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indication Use For EMS (Code 10, 20-22,30-33_) Only Relax muscle Spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Indication Use For IF (Code 11-18, 20-22,30-33) 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. Powered muscle stimulators should only be used under medical supervision
    Device Description
    The SDS-41 like a number of legally marketed predicate devices incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. The SDS-41 is housed in a plastic enclosure. The front of the enclosure house character LCD display. The accessories provided with the SDS-41 include the output cable, the electrode pads, and the AC Charging Adapter. The SDS-4I muscle stimulation modality operates at a specified 23 volts max (into a 500 ohm load) and 46mA max (into a 500 ohm load) with a pulse width of 520us Max and a cycle frequency of 75 Hz (±5%). The pulse is Symmetrical bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting. The SDS-4I interferential modality operates at a specified 80 mA max (into a 500 ohm load). The carrier and interferential signals are sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference Signal frequency can be fixed (continuous) or carried based on three selections (variable).
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    K Number
    K002832
    Device Name
    CONDUCTIVE GEL FOR ULTRASOUND
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2001-08-06

    (329 days)

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

    **SKYLARK DEVICE **& SYSTEMS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992652
    Device Name
    SD-730 IF-SDS, PERFECT PULSE IF-SDS
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2000-02-03

    (181 days)

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

    **SKYLARK DEVICE **& SYSTEMS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1.Symptomatic relief of chronic, intractable pain 2.Management of pain associated with post-traumatic or post-operative conditions
    Device Description
    Not Found
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    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

    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

    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

    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

    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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