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510(k) Data Aggregation

    K Number
    K132057
    Device Name
    DYNATRON PELTIER THERMOSTIM PROBE
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2014-01-24

    (205 days)

    Product Code
    GXY, DYN, ILO
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.
    Device Description
    The Dynatron Peltier ThermoStim probe is used to provide therapeutic electrical stimulation and thermal therapy treatments. The probe consists of a handle with a treatment head and connections to a Dynatron Solaris series controlling console for power and communications with a port for connection to electrical stimulation outputs. The probe acts as an electrode for therapeutic electrical current provided by a Dynatron Solaris device in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) supplied from a thermo-electric chip. The probe is a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatron Solaris series electrical stimulation devices. The probe has a rectangular wedge treatment face of approximately 1¼³ x 2¼" with rounded edges. The maximum surface area that could come in contact with a patient is approximately 38 cm-.
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    K Number
    K113250
    Device Name
    DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2012-02-09

    (98 days)

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

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
    Device Description
    The Dynatron Tri-wave™ light pad and Dynatron Tri-wave™ light probe generate therapeutic topical heating treatments through the medium of multi-wavelength light energy to targeted tissue. The Dynatron Tri-wave™ light pad is a bifurcated pad with two 5" x 7" treatment pads connected by a 24" cable between them and a 72" cable connecting to the Dynatron Solaris plus™ controlling console. The two pads accommodate treating both sides of a shoulder, elbow, knee, etc. or may be used side by side to treat larger areas such as the lower back. The Dynatron Tri-wave™ light probe is designed with super luminous diodes emitting three different wavelengths of light. The Infrared LEDs have a wavelength of 850nm, the Red LEDs have a wavelength of 624nm and the Blue LEDs have a wavelength of 464nm. The light probe handle has an ergonomic design and is suited for treating small areas such as the hand, wrist or neck.
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    K Number
    K060814
    Device Name
    DYNATRON ION IONTOPHORESIS ELECTRODE
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2006-06-14

    (79 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynatron® Ion™ iontophoresis electrode is designed for clinical use to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. The Dynatron® Ion™ iontophoresis electrode is indicated to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection
    Device Description
    The Dynatron® Ion™ iontophoresis electrode consists of an active drug delivery electrode and a return electrode. Electrodes are designed for single patient use.
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    K Number
    K051680
    Device Name
    DYNATRON DX2 TRACTION UNIT
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2005-10-11

    (110 days)

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

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynatron DX2 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. The Dynatron DX2 also functions as a system console for controlling the function of infrared therapy devices such as the Dynatron D880 (K031329) and the Dynatron D890 (D040729). Indications for use of these infrared therapy devices are to provide topical heating for temporary increase in blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness associated with arthritis.
    Device Description
    Components: System console, model Dynatron DX2, containing electric motor and control electronics with LCD alpha-numeric display. Pull-head or Goniometer attaches patient harnesses and applied force. Feedback from the Goniometer displays force applied and angle of force. Accessories such as traction belts. Output ports on the back of the DX2 system console accommodate infrared therapy devices such as the Dynatron D880 (K031329) and Dynatron D890 (K040729).
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    K Number
    K051261
    Device Name
    DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2005-07-25

    (70 days)

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

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
    Device Description
    The Dynatron® Solaris™ model numbers X3, Dynatron Xp, and D405) provide infrared (IR) therapy. Components: System console, model Dynatron X3, containing software and control electronics with alpha-numeric displays. Infrared pad, model Dynatron Xp, for administering IR therapy. Hand-held infrared probe, model D405, for administering IR therapy. Accessories such as power cord.
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    K Number
    K043047
    Device Name
    DYNATRON IBOX IONTOPHORESIS DEVICE
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2005-01-07

    (64 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynatron® IBox™ is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.
    Device Description
    The Dynatron® IBox™ is an iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue. The Dynatron® IBox™ is a battery powered, solid state, microprocessor-controlled unit that delivers measured, displayed direct current as defined by the user. Treatment duration is also measured and displayed. The device connects to any number of existing electrodes cleared for marketing in the United States that have a common snap connection. Device output is functionally identical to predicate devices.
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    K Number
    K040729
    Device Name
    SOLARIS D890 THERAPY PROBE
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2004-06-02

    (72 days)

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

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
    Device Description
    The Solaris D890™ is an infrared therapy accessory probe for use with Solaris Series combination devices. The base Solaris devices provide the operational power and software. The D890 probe contains only an on/off switch and requisite software to drive the infrared energy source.
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    K Number
    K031329
    Device Name
    DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2003-10-22

    (177 days)

    Product Code
    IMI, GZJ, ILY, IPF, LIH
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynatron Solaris Series of products, including Solaris 709, 708, 706, and 705, provide electrical stimulation, ultrasound and/or combination electrical stimulation and ultrasound, as well as infrared therapy. 1) Electrical Muscle stimulation therapy for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion 2) Transcutaneous electrical nerve stimulation and Interferential Current Therapy for: Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain. 3) Ultrasound therapy for: Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as: Relief of pain Muscle spasms Joint contractures 4) Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
    Device Description
    The Dynatron® Solaris™ Series (Model numbers 709, 708, 706, and 705) provide electrical stimulation, ultrasound, and/or electrical stimulation and ultrasound, as well as optional infrared therapy. Components: System console, containing software and control electronics with alpha-numeric displays Ultrasound transducer, infrared probe, and multi-probe for administering electrotherapy Accessories such as patient cables, electrodes, transducer gel and elastic straps.
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    K Number
    K010565
    Device Name
    DYNATRON STS
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2001-05-15

    (78 days)

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

    DYNATRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010948
    Device Name
    DYNATRON STS RX
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2001-05-15

    (47 days)

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

    DYNATRONICS CORP.

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

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