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510(k) Data Aggregation

    K Number
    K202490
    Device Name
    Avid CT2
    Manufacturer
    Vision Quest Industries Inc./dba VQ OrthoCare
    Date Cleared
    2020-11-16

    (77 days)

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

    /dba VQ OrthoCare

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interferential Stimulation can be used in the following applications: - · Symptomatic relief of post-surgical and/or post traumatic acute pain - · Symptomatic relief of chronic intractable pain - Relaxation of muscle spasms - Maintain or increase range of motion - Increase local blood circulation Neuromuscular Stimulation can be used in the following applications: - · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis - · Prevention or retardation of disuse atrophy - · Muscle-re-education
    Device Description
    The Avid CT2, Model AV-CT20A is a combination therapy device. Like its predicate Avid IF2, it is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad. The primary difference between the two devices is the addition of user- adjustable parameters that allow the existing interferential waveform to turn on and off within a small, preselected range to provide necessary control for neuromuscular stimulation. This same method of gating the interferential on and off was used in VQ's previous Surgi Stim stimulator.
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    K Number
    K183692
    Device Name
    Avid IF2
    Manufacturer
    Vision Quest Industries Inc./ dba VQ OrthoCare
    Date Cleared
    2019-06-12

    (163 days)

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

    / dba VQ OrthoCare

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications: - -Symptomatic relief of post-surgical and/or post traumatic acute pain - -Symptomatic relief of chronic intractable pain -Relaxation of muscle spasms -Maintaining and increasing range of motion -Increases local blood circulation
    Device Description
    The Avid IF2, Model AV-IF19A is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad.
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    K Number
    K153374
    Device Name
    CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
    Manufacturer
    ORTHOCARE
    Date Cleared
    2016-06-17

    (207 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). CARE Brand of DHS/DCS Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only.
    Device Description
    CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws. The plates and screws are fabricated from Stainless Steel and Titanium. The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T- Plates, Anatomical Plates, Clavicle Hook Plates. These all are mainly divided into - DHS/DCS Plates. - Large Fragment Plates - Small Fragment Plates - Mini Fragment Plates The number of the holes varies from 2 to 22. The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm. The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 74mm. CARE Brand of DHS/DCS Plating System consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw (Standard and Self Tapping). The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel angels varies from 130° to 150°. The DHS/DCS Screw is available in total length from 50 to 120 mm. thread length 22mm. shaft diameter of 12.5. The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 3.8 mm. These devices are not indicated for use in spine. These implants are supplied non-sterile, the products have to be sterilized prior to use.
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