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510(k) Data Aggregation

    K Number
    K172536
    Device Name
    Atlas Percussion Adjusting Instrument
    Manufacturer
    Spinalight, Inc
    Date Cleared
    2018-06-20

    (302 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spinalight, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.
    Device Description
    The Percussion Adjusting Instrument is comprised of a Chiropractic Adjusting Table and a support system with a percussion device, which a Chiropractor positions over his patient to deliver an adjustment to the Atlas Vertebra (C-1). After the doctor positions the patient on the table, he aligns the instrument head so that the stationary stylus is positioned to the Atlas on predetermined vectors. Once this is completed the Chiropractor activates a solenoid contained within the adjusting head which strikes the proximal end of the stationary stylus generating a percussion wave through the stylus into the transverse process of the Atlas Vertebra. The objective is to produce a movement of the Atlas toward its proper alignment under the skull. Any time the patient is being positioned on the table or headpiece the percussion head is placed in the "Safe to Move" position.
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    K Number
    K001476
    Device Name
    TORQUE INSTRUMENT, MODEL 8500
    Manufacturer
    SPINALIGHT, INC.
    Date Cleared
    2000-08-04

    (85 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPINALIGHT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955540
    Device Name
    HAND HELD ATLAS INSTRUMENT
    Manufacturer
    SPINALIGHT, INC.
    Date Cleared
    1996-03-04

    (90 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPINALIGHT, INC

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

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