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510(k) Data Aggregation

    K Number
    K243112
    Device Name
    Curapuls 670
    Manufacturer
    Enraf-Nonius, B.V.
    Date Cleared
    2025-06-25

    (268 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curapuls 670 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
    Device Description
    The Curapuls 670 is a two-channel microprocessor-controlled unit for pulsed shortwave therapy. Through inductive electrodes (Circuplodes), high-frequency electric currents are produced within the body. Pulsed energy at 27.12 MHz is absorbed by soft tissues. Three sizes of Circuplodes (140mm, 90mm and elliptical) are available to accommodate different size treatment areas. Deep heating of tissue is achieved with ease by means of inductive electrodes. The user can connect two applicators. Activation of each applicator can be controlled from the console menu. This device is a prescription equipment. Use by any persons other than physicians is prohibited.
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    K Number
    K223620
    Device Name
    Reprieve by RegenesisTM
    Manufacturer
    Regenesis Biomedical Inc.
    Date Cleared
    2023-05-24

    (170 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprieve by Regenesis™ device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
    Device Description
    The Reprieve by Regenesis™ device (Reprieve) is a prescription shortwave diathermy (SWD) device consisting of a single base unit connected to one or two treatment applicators. The device connects to A/C power through an external, off-the-shelf, power supply generating radiofrequency energy which delivers SWD through the treatment applicator(s). The base unit houses an LCD screen with four raised buttons, two on each side of the LCD screen, and an LED light bar. The back of the base unit has a molded slot to accommodate the treatment applicator(s), a pouch to store the power supply, and a cable wrapping loop to organize the treatment applicator cables. The bottom of the base unit has an opening to connect the A/C power supply. The treatment factory-affixed coaxial cables. The top is the treatment side of the applicator is a darker color to distinguish it from the lighter-colored bottom, the non-treatment side. The top also has circular imagery denoting the center of the applicator. The Reprieve device generates a 27.12 MHz RF signal that has a 100% duty cycle when programmed to continuous wave (CW) mode. When prescribed for pulsed wave (PW) mode, the pulse rate (e.g., pulses per second) can be varied from 200Hz to 1000Hz in 200Hz increments, and the pulse width (e.g., the elapsed time the pulse is on) from 20µsec to 100µsec in 20µsec increments.
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    K Number
    K182363
    Device Name
    BTL-703
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2019-01-24

    (147 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
    Device Description
    The BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The BTL-703 consists of the following main components: microprocessor-driven control unit, high-frequency energy generator, user interface with 15,6" HD touch screen, four-point applicator.
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    K Number
    K173300
    Device Name
    ViaTherm BOOST
    Manufacturer
    ViaTherm Therapeutics, Llc.
    Date Cleared
    2018-05-01

    (196 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
    Device Description
    The ViaTherm BOOST Diathermy System is a single-patient reusable device designed to be self-administered in the home by a non-technical, adult operator. Diathermy is the controlled production of "deep heating" beneath the skin in the subcutaneous tissues, deep muscles and joints for therapeutic purposes. The ViaTherm BOOST Diathermy System is a portable diathermy heat therapy system that uses a shortwave radiofrequency signal to provide diathermic heating of tissue. The ViaTherm BOOST Diathermy System consists of five (5) components: Power generator, Heat applicator garment, Battery charging cable, Velcro extender strap, Cotton pad. Electronic circuitry in the power generator components generates a radiofrequency (RF) signal at a frequency of 13.56 Megahertz (MHz). The radiofrequency signal is delivered to the heat applicator garment that uses induction coil (magnetic field) technology to produce electromagnetic fields external to the applicator. This energy is converted into heat by electromagnetically resistant body tissues. The power generator consists of a battery pack, voltage regulators, a power control and analogue sensor module, and an RF generator. A shielded 1/4" cable with 50 Ohms impedance connects the power generator to the heat applicator garment. The electrode consists of two flat spirals incorporated into the applicator garment. The spirals are each tuned to 50 Ohms. The power from the generator is split and sent to the two spirals, one of which is driven 180 degrees out of phase from the other.
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    K Number
    K162240
    Device Name
    ProMedTek Model C1400 Shortwave Diathermy Device
    Manufacturer
    PROMEDTEK INC.
    Date Cleared
    2016-11-17

    (100 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as: 1. Relieving pain 2. Reducing muscle spasm 3. Increasing range of motion of contracted joints using heat and stretch techniques 4. Increasing blood flow to tissues in the treatment area.
    Device Description
    The ProMedTek C1400 shortwave diathermy device operates at 27.12 MHz. It provides traditional shortwave diathermy using an inductive drum or soft-rubber electrodes. The unit offers both continuous or pulsed modes of operation with a variety of frequencies and pulse widths to choose from. An easy-to-use LCD Touch Screen guides the user through setup. A Patient Safety Pull-Cord allows the patient to stop all output. The base of the ProMedTek C1400 is a sturdy cart with large locking wheels that allows the ProMedTek C1400 to be moved easily around the clinic and supports the arm and drum applicator during treatment.
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    K Number
    K161862
    Device Name
    ThermoPro
    Manufacturer
    Zimmer MedizinSysteme GmbH
    Date Cleared
    2016-11-14

    (131 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases. Generally accepted indications for use: o Pain Relief - o Contractures - o Reduce Muscle Spasm - o Localized increase Blood Flow - o Chronic Inflammatory Conditions - o Bursitis - o Decrease Joint Stiffness - o Tenosynovitis - o Synovitis - o Chronic Inflammatory Pelvic Disease
    Device Description
    ThermoPro is a shortwave diathermy device for use in applying therapeutic deep heat for selected medical conditions by applying electromagnetic energy in the radio frequency band of 27.12 MHz. The ThermoPro is a device with a metal enclosure that includes a display touchscreen. The device also features an applicator that is a standard monode electrode. The applicator is connected to the device housing, where an electronic power module drives electromagnetic energy into applicator. This electromagnetic energy is generated using a sine wave synthesizer in combination with a RF power amplifier. The energy can be applied either in constant wave mode or in pulsed mode.
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    K Number
    K153456
    Device Name
    Megapulse III Shortwave Diathermy
    Manufacturer
    Accelerated Care Plus
    Date Cleared
    2016-06-14

    (196 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects: - · Relieves pain - · Increases the extensibility of collagen tissues - · Decreases joint stiffness - · Relieves muscle spasm - Increases local blood flow Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications: - · Disorders of the musculoskeletal system - o Muscle spasm - o Joint stiffness - o Joint contractures - · Chronic inflammatory or infective conditions - o Tenosynovitis - o Bursitis - o Synovitis - o Chronic inflammatory pelvic diseases
    Device Description
    Not Found
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    K Number
    K131926
    Device Name
    THERMOPULSE
    Manufacturer
    IBRAMED EQUIPAMENTOS MEDICOS
    Date Cleared
    2014-07-24

    (393 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K131899
    Device Name
    SW-THERM
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
    Date Cleared
    2014-03-14

    (262 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SW-Therm, Model ST 1001, is intended to deliver energy in the radio band of 27.12 MHz to provide deep heating therapeatic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as: I ) Relieving pain; 2) Reducing muscle spasm; 3) Increasing range of motion of contracted joints using heat and stretch techniques; and 4) Increasing blood flow to tissues in the treatment area.
    Device Description
    Not Found
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    K Number
    K121123
    Device Name
    BIOFUSIONARY BEBE
    Manufacturer
    ROCKY MOUNTAIN BIOSYSTEMS, INC.
    Date Cleared
    2014-03-10

    (696 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Product Code :

    IMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biofusionary Bebe System is indicated to be used to generate deep heat within body tissues for treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
    Device Description
    The Biofusionary Bebe is used for diathermic heating of tissue. The Biofusionary Bebe hand piece tip is comprised of a coil shaped antenna which directs the flow of current parallel to the tissue surface, without contacting the tissue surface, thereby directing the magnetic component of the electromagnetic energy into tissue to result in the formation of eddy currents in tissue. These eddy currents encounter resistance, leading to localized heating.
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