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510(k) Data Aggregation

    K Number
    K143737
    Device Name
    EM25 - glute toning device
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2015-07-27

    (209 days)

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

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles.
    Device Description
    The proposed device, EM25 - glute toning device is a self-adhesive EMS device for muscle training. The device can be applied with accuracy thanks to the use of EMS technology. Made from medical-quality silicone rubber, the elegantly designed EMS pad is extremely slim and flexible and adapts perfectly to the area to be treated. The high-tech circuit provides energy-efficient treatments of 20 minutes each. Electrical muscle stimulation (EMS) is a widespread and generally recognized method and has been used in sports medicine and rehabilitation for years. In sports and fitness, EMS is used to complement conventional muscle training, to increase the performance of muscle groups and to adjust physical proportions to achieve the desired aesthetic results. EMS devices work by passing electrical currents over the skin. The gel pad is used as a transfer medium and is subject to natural wear and tear. The gel pad must be replaced if it stops providing sufficient contact, as this will prevent the EMS pad from sticking to the skin. If it is not replaced, the partially increased current density could irritate the skin. The proposed device, EM25 - glute toning device is assembled with the PCBA and electrode, and the LR03 (AAA) battery supplies the safe low-frequency current. The electrode stuck on the human skin purposes to train the deep muscle. There are 0-15 intensity levels for EM25 - glute toning device. The maximum voltage is divided by 15 (levels) and accumulated for each voltage. But the each increased amperage cannot be over 2%. The intensity level will be minimum when turning on. The user can adjust it from 0 to 15 and gradually increase the intensity level. The whole treatment time is 20 minutes, and then the device switches off automatically.
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    K Number
    K141921
    Device Name
    HIVOX SPOPAD EMS
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2015-01-16

    (184 days)

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

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
    Device Description
    These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.
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    K Number
    K131720
    Device Name
    HIVOX SELF ADHESIVE ELECTRODE GEL PADS
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2014-07-25

    (408 days)

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

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode itself.
    Device Description
    HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same materials from the predicate suppliers, i.e. K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile, self-adhesive, for single patient use only, and to be disposable.
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    K Number
    K140650
    Device Name
    HIVOX ELECTRIC STIMULATOR OTC TENS
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2014-06-27

    (106 days)

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

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg), and lower back due to strain from exercise or normal household and work activities.
    Device Description
    The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, can generate small pulses of electrical current and delivered these pulses pass through the skin and activated underlying nerves.
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    K Number
    K112392
    Device Name
    HIVOX BIOTEK INC.
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2012-03-19

    (214 days)

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

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
    Device Description
    The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.
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    K Number
    K092448
    Device Name
    HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2010-03-30

    (232 days)

    Product Code
    GZJ, CLA, IPF
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TENS programs of HIVOX Electric Stimulator TENS & EMS, HD2: The device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems. The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2: The device is an electrical powered muscle stimulator indicated for medical purpose to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.
    Device Description
    The HIVOX Electric Stimulator TENS & EMS, HD2 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the HD2 can provide results from this electrical stimulation.
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    K Number
    K021952
    Device Name
    HIVOX DREAMATE DM-800
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2003-05-02

    (323 days)

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

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    used to apply a minor electrical current to electrodes on patient's wrist skin to function as: - Helping relieve nausea and vomiting due to motion sickness.
    Device Description
    Not Found
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    K Number
    K020471
    Device Name
    HIVOX EAR THERMOMETER, TS SERIES
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2002-05-02

    (79 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIVOX BIOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an electronic clinical thermometer using an infrared thermopile sensor to detect body temperature of the radiation from the tympanic part of the human of all ages at home.
    Device Description
    AVITA TS0/TS1 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (Tympanic Temperature).
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