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510(k) Data Aggregation

    K Number
    K220514
    Device Name
    bite away neo
    Manufacturer
    MibeTec, GmbH
    Date Cleared
    2022-06-23

    (121 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bite away® neo is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes.
    Device Description
    The bite away® neo device is a light weight, portable, hand-held, battery powered, user- operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 5 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 5 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 5 seconds; limiting the maximum amount of heat to be delivered to the site. The bite away® neo device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 7mm ceramic disc to approximately 50°C when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button. AA batteries, and a heated ceramic plate that contacts the printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer. The bite away® neo device is approximately 7 inches long and weighs approximately 40 grams.
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    K Number
    K160943
    Device Name
    Bite Away
    Manufacturer
    Riemser Pharma
    Date Cleared
    2016-08-26

    (143 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bite Away is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes by temporarily increasing localized blood flow.
    Device Description
    The Riemser Pharma Bite Away device is a light weight, portable, hand held, battery powered, user-operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 6 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 6 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 6 seconds; limiting the maximum amount of heat to be delivered to the site. The Riemser Pharma Bite Away device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 9mm ceramic disc to 51.5℃ +/- 1% when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds or 6 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button, AA batteries, and a heated ceramic plate that contacts the patient. The printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer. The Riemser Pharma Bite Away device is approximately 6 inches long and weighs approximately 25 grams. The Bite Away device is provided in 2 shapes, both of which are identical in every way except for the shape. One product is an elongated configuration called "Cobra" and the other configuration is an oblong configuration called "Mouse". Although these products have different shapes and names, the products are identical in every way to include raw materials, subcomponents, electronic circuits, electronic components, and imbedded software code, fabrication processes, etc., and only differs in the shape of the outer case (elongated Cobra model versus the oblong Mouse model).
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    K Number
    K142228
    Device Name
    Heated Eye Pad
    Manufacturer
    Digital Heat Corporation
    Date Cleared
    2015-02-09

    (180 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heated Eye Pad ophthalmic warmer is a powered heating pad for the application of localized heat therapy. Use for treatment when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia.
    Device Description
    Not Found
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    K Number
    K133981
    Device Name
    AVACEN 100
    Manufacturer
    AVACEN INC.
    Date Cleared
    2014-08-15

    (232 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffiess; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.
    Device Description
    The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
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    K Number
    K111273
    Device Name
    FIR HEAT THERAPHY SYSYEMS
    Manufacturer
    SHENZHEN ANPAN TECHNOLOGY CO., LTD.
    Date Cleared
    2011-11-08

    (188 days)

    Product Code
    IRT, ILY
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FIR Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
    Device Description
    The FIR Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nyloncotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
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    K Number
    K072534
    Device Name
    BIO-MAT 2000
    Manufacturer
    RICHWAY INTL., INC.
    Date Cleared
    2008-02-08

    (154 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.
    Device Description
    The Bio-Mat is an electrically powered mattress pad that applies infrared heat to the user's body for the temporary relief of minor body aches and pains. A control panel allows the user to turn the product on/off, modify the temperature, and set the product's timer.
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    K Number
    K963887
    Device Name
    PT-PAC PORTABLE HEATING PAD
    Manufacturer
    ANTHONY A. CHIURCO
    Date Cleared
    1997-03-31

    (186 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The PT-Pac is a portable heating pad. It is a non-significant risk device similar to predicate devices (powered heating pads 890.5740) in providing sustained electrical powered heat to a defined body region. As with approved heating pads, the skin contacts only a biocompatible (100% cotton) cover. The PT-Pac claims the ability to provide soothing warmth in the temperature range of predicate devices. PT-Pac differs from alternating current powered devices in that it is powered by low-voltage, direct-current batteries, making it portable as well as safer than conventional heating pads. The PT-Pac uses highly reliable thermoelectric tiles to transfer heat. These are microprocessor-controlled, providing strict temperature regulation. The redundancy of two safety circuits, together with the finite time that the batteries can power the unit, make the safety of this device more robust than that of predicate devices.
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    K Number
    K963824
    Device Name
    LI'S ITCH STOPPER
    Manufacturer
    HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY
    Date Cleared
    1996-12-12

    (80 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962195
    Device Name
    HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3
    Manufacturer
    SUNBEAM HEALTH DIVISION
    Date Cleared
    1996-11-27

    (173 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use wherever hot applications are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.
    Device Description
    Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL Standard #130, Electric Heating Pads, operating on standard 110-120V household current. The units are supplied with removable covers and sponge inserts for moist heat applications, with instructions, in conventional 4-color printed boxes, and are marketed through consumer retail channels.
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    K Number
    K962252
    Device Name
    HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4
    Manufacturer
    SUNBEAM HEALTH DIVISION
    Date Cleared
    1996-11-25

    (166 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Product Code :

    IRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use wherever applications of heat, massage, or both are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.
    Device Description
    Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL Standard #130, Electric Heating Pads, operating on DC 9V current supplied through a standard adapter. The units are supplied with removable covers and sponge inserts for moist heat applications, with instructions, in conventional 4-color printed boxes, and are marketed through consumer retail channels.
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