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510(k) Data Aggregation

    K Number
    K213078
    Device Name
    Myolift QT
    Manufacturer
    Johari Digital Healthcare Limited
    Date Cleared
    2023-04-27

    (581 days)

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

    Johari Digital Healthcare Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Myolift QT" is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
    Device Description
    The MyoliftQT is a microcurrent, handheld, and mobile application-based device which is easy to operate. The mobile application used in the device supports both types of users (iPhone®/Android™). The user has to download the application via Google Play™ store (Android) /App Store® (IOs) and connect the device via Bluetooth of their phone. The users can thereafter make their profiles accordingly. The purpose of this device is to lift and tone the face and neck. It is a battery-powered device used with conductive gel. The conductive gel is used to reduce the impedance between the electrodes and the skin of the user. Myolift QT has one channel and two output ports. One output is through the applicator ball and the other output is through the lead wire via the USB port connected through the charging port. The Lead wire is connected to the device via USB. And electrodes are connected through the lead wire to give skin treatment to the user. The Metal balls and the electrodes are in contact with the user/patient maximum of 60 min, therefore the Surface-contacting, less than 24hour duration. The Sphere shape applicator balls made up of stainless steel in this device are designed to gently roll over the skin to deliver low-level electrical impulses in the face and neck region. The device delivers current in the range of 350 microamperes and low 160-microampere current. Note: During treatment, only one output port works. In skin treatment, the device minimize the fine lines and wrinkles on the skin. This device delivers two types of waveforms (Erase and Educate) for effective skincare treatment. It is intended to be used by multiple users (multiple applications). The device can be switched ON|OFF by simple touch on the power button. The device offers multiple LED indications (Visual) to indicate the different states of the device. - -A flashing blue LED light indicates that the device is ON|OFF and when the device is connected to Bluetooth, the flashing blue light becomes steady. - -A Red LED indicates battery low while A Green LED indicates the chagrining of the device lt is a portable device having dimensions 6.65″ x 1.49″ [ L X B X H ]. Its outer case is made up of thermoplastic resin. The device comes with a C-type USB cable for the charging of the device. The device is automatically turned off if it is not connected via Bluetooth or not operated for more than 10 minutes.
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    K Number
    K212866
    Device Name
    truSculpt flex
    Manufacturer
    Johari Digital Healthcare Limited
    Date Cleared
    2022-12-03

    (451 days)

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

    Johari Digital Healthcare Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    truSculpt flex is indicated to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, toning and firming of buttocks & thighs.
    Device Description
    truSculpt flex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks. truSculpt flex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.
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    K Number
    K192039
    Device Name
    Torc Body
    Manufacturer
    Johari Digital Healthcare Limited
    Date Cleared
    2020-03-29

    (243 days)

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

    Johari Digital Healthcare Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Torc Body is indicated to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, toning and firming of buttocks & thighs.
    Device Description
    Torc Body, the Powered Muscle Stimulator, is intended to improve tone and strengthen the muscles of the abdomen, buttocks, and thighs and to firm the abdomen muscles. The modified Torc Body, as described in this submission, is an upgrade from its previous version; which includes User- Friendly GUI, Internal power supply, and a wheeled console allowing clinicians to navigate and operate the device effortlessly. We intend to market this device to clinicians, as a prescription device. For ease of use and operation for the clinicians, we have 3 modes (suggestive): CLASSIC VECTOR, POWER SEQUENCE, DYNAMIC ROTATION. The modified device generates electrical stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
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