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510(k) Data Aggregation

    K Number
    K033015
    Device Name
    AXIOM BIOLASER LLLT SERIES-3
    Manufacturer
    AXIOM USA. INC
    Date Cleared
    2003-11-25

    (60 days)

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

    AXIOM USA. INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axiom BioLaser LLLT Series-3 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
    Device Description
    The Axiom Bio LLLT Series -3 is a non thermal triple diode infrared laser.
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    K Number
    K030622
    Device Name
    AXIOM BIOLASER LLLT SERIES-1
    Manufacturer
    AXIOM USA. INC
    Date Cleared
    2003-09-09

    (194 days)

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

    AXIOM USA. INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axiom BioLaser LLLT Series-1 is for adjunctive use in providing temporary relief of minor chronic Neck and shoulder pain of musculoskeletal origins.
    Device Description
    The Axiom Bio Laser LLT Series - 1 is a single diode laser which produces an Output power of no more than 5 mW of energy with a 660 nm wavelength.
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    K Number
    K022602
    Device Name
    DRX3000
    Manufacturer
    AXIOM USA. INC
    Date Cleared
    2003-01-23

    (170 days)

    Product Code
    ITH, DRX
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXIOM USA. INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRX3000 provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRX3000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
    Device Description
    Device Trade Name: DRX3000 Traction Equipment Common Name: Power Traction Equipment Classification Name: Power traction equipment Class and Reference Product Code: Class II (21 CFR Section 890.5900) 89 ITH
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    K Number
    K023160
    Device Name
    DRX5000
    Manufacturer
    AXIOM USA. INC
    Date Cleared
    2002-12-20

    (88 days)

    Product Code
    ITH, PAN
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXIOM USA. INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRX5000 provides a program of treatments for relief from pain for those patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the DRX5000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
    Device Description
    The DRX5000 is a powered traction equipment device. The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to step onto a footrest while it is in near vertical position. The bed and patient can then be slowly lowered to the horizontal treatment position using a remote controller hand held by the practitioner. The bed is split into two cushions, each slide able in the horizontal plane only on low friction runners and each being able to be locked independently. Distraction tensions are applied to the patient via a pelvic harness while the upper body of the patient is anchored to the locked upper cushion via a chest harness. The lower cushion, which is unlocked and on which the patient's lower trunk is rested, is able to slide easily thus reducing almost completely any frictional movement between patient and bed cushion when distraction tensions are applied, this concentrates virtually all the forces to the affected part of the lumbar spine. The traction unit is mounted to the foot of the tower and the belt pulley system is attached to a vertical movable platform incorporated into the tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles to the patient (between 0 and 30 degrees). The traction unit is programmed and controlled from a control panel fitted into the tower to give static or intermittent distraction. The minimum and maximum distraction settings are 0-200 lbs. Treatment parameters i.e. tensions and time are continuously monitored and shown by LCD readout at the time of treatment set up and during treatment. At the conclusion of treatment time, tension always returns to zero. A DVD player, which is incorporated in a separate section of the control panel, and headphones provide comfort and relaxation to the patient and provides and opportunity for patient education via clinical tapes. There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button, or Emergency Stop on the control panel has been pushed by the practitioner. The DRX5000 will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment. The treatment cannot be restarted when a patient activates the Patient Safety Switch or the Stop Button has been pushed during treatment unless all treatment parameters are manually re-entered into the controller.
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