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510(k) Data Aggregation

    K Number
    K241395
    Device Name
    Active System; Avenue8
    Manufacturer
    Caerus Corporation
    Date Cleared
    2024-12-18

    (216 days)

    Product Code
    ILX, IMD, IRT
    Regulation Number
    890.5290
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
    Device Description
    The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately. The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.
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    K Number
    K223308
    Device Name
    HEATING TENS/EMS, FT-810R
    Manufacturer
    Hivox Biotek Inc.
    Date Cleared
    2023-05-13

    (197 days)

    Product Code
    NUH, IRT
    Regulation Number
    882.5890
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
    Device Description
    The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime. TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear and must be replaced when they stop providing sufficient contact or the main device no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
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    K Number
    K221251
    Device Name
    Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
    Manufacturer
    Guangzhou Hua Kai Electronic Technology Co., Ltd.
    Date Cleared
    2022-07-29

    (88 days)

    Product Code
    NUH, IRT, NGX
    Regulation Number
    882.5890
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (mode 4-6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. Heating: This function is designed to be used for temporary relief of minor aches and pains.
    Device Description
    Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities. Ems Foot Stimulator has 6 modes (PMS mode 1~3, TENS mode 4~6), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area. The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key. The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode. The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key. The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 degree C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously. There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different.
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    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
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    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
    K213091
    Device Name
    Well-Life TENS/EMS/Heating Stimulator
    Manufacturer
    Well-Life Healthcare Limited
    Date Cleared
    2022-02-19

    (148 days)

    Product Code
    NUH, IRT, NGX
    Regulation Number
    882.5890
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following: TENS can be used for the following applications: - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities. EMS can be used for the following applications: - For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. Heat Mode: - Heat can be used for temporary relief of minor aches and pains.
    Device Description
    Well-Life OTC TENS/EMS/Heating Stimulator Device, Model no. WL-2405K* provides a combination of transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work related activities, Electrical Muscle Stimulator (EMS) can be used to stimulate healthy muscles in order to facilitate muscle performance, relax muscle spasms, prevent or retard disuse atrophy, reeducate muscles and to maintain or increase the range of motion, Heat can be used in warming the muscle for soothing comfort. The stimulator generates the output current specified as the input of controller. The output port transmits the output current & heat to the electrode, which is attached to the user's skin ; ; with the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back, upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities, and to be used to stimulate healthy muscle in order to improve and facilitate muscle performance. The device includes several operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS/EMS and heat. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43°C. For the heating cycle, the temperature will get to 43 degree Celsius in 130 seconds after turning on the heating mode, and when it reaches 43 degree Celsius then it will cool down to body temperature for 20 seconds, then back to 43 degree Celsius for 20 seconds , the cycle will continue for 15 minutes. The device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature. Channel 1 can provide electrical stimulation signal, such as TENS/EMS, and it can only be performed by connecting an electrode and wire dedicated to electrical stimulation. Channel 2 can provide heat treatment, and it can only be carried out by connecting heat-exclusive electrode and wires. The exclusive accessories used for electrical stimulation or thermotherapy are marked by color to prevent misuse by the user. If you accidentally use it incorrectly, there will be a protective mechanism in the device to prevent it from operating and causing harm.
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    K Number
    K203574
    Device Name
    HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
    Manufacturer
    Hivox Biotek Inc.
    Date Cleared
    2021-03-10

    (93 days)

    Product Code
    NUH, IRT, NGX
    Regulation Number
    882.5890
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HIVOX OTC Electrical Stimulator, EM59-1 TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. SH: This function is designed to be used for temporary relief of minor aches and pains. HIVOX OTC Electrical Stimulator, EM59-2 TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. SH: This function is designed to be used for temporary relief of minor aches and pains.
    Device Description
    HIVOX OTC Electrical Stimulators, EM59-1 and EM59-2, fall into the electrostimulation device category. EM59-1 provides two basic functions, TENS and SH; EM59-2 provides three basic functions, TENS, EMS and SH: (1) Electrical stimulation of nerve tracts (TENS) (2) Electrical stimulation of muscle tissue (EMS) (3) Superficial heat (SH) Both two models feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general wellbeing, pain relief, maintaining physical fitness, relaxation, muscle revitalisation and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. The size of the self-adhesive electrode gel pad is 45x45 mm supplied by Shaoxing DL Healthcare Co., Ltd. It is an OTC medical device cleared by FDA under K182111. On the other hand, the electrode made by PET, sponge, PCB and protect cases is designed by HIVOX BIOTEK INC.
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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
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    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
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    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
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    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
    K111341
    Device Name
    CLEANE / CLEANE POP
    Manufacturer
    MEDICON CO., LTD.
    Date Cleared
    2012-02-29

    (293 days)

    Product Code
    OZC
    Regulation Number
    890.5740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLEANE and the CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
    Device Description
    The CLEANE and the CLEANE POP are potable had-held devices that produce accurately controlled low level sustained heat for use in treating mild to moderate acne. The devices are designed to treat individual acne blemishes for 2 1/2 minutes at a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.
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