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510(k) Data Aggregation

    K Number
    K214015
    Device Name
    Palm NRG cellulite body device (model: Palm NRG body device)
    Manufacturer
    Heat In A Click LLC.
    Date Cleared
    2022-09-26

    (278 days)

    Product Code
    PBX, GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heat In A Click LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
    Device Description
    Palm NRG cellulite body device (model: Palm NRG body device) is a portable, non-invasive, at home skin care device. It works for with radio frequency (RF) to help users to enjoy the care skin. The device is a noninvasive, non-ablative device and it is supplied as non-sterile, it has 2 buttons, one for power on/off, the other one for level adjust. The main unit is equipped with accessories of an adapter and a charging base. The charging base is used to connect the adapter and the main unit.
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    K Number
    K202055
    Device Name
    Looper (Model: ZX-579S)
    Manufacturer
    Heat In A Click LLC
    Date Cleared
    2021-04-16

    (266 days)

    Product Code
    OLP, OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heat In A Click LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory acne.
    Device Description
    Looper (Model: ZX-579S) is a hand-held device for over-the-counter aesthetic purposes, it's a multifunctional comprehensive beauty instrument. It's combined with the two kinds of operation functions: SONIC and PHOTON mode. Sonic mode: The Sonic waves can provide vibrating to facial skin. The device provides 5 vibration intensities for users to choose from. Photon mode: The red light is intended for use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of facial wrinkles. The therapeutic probe is designed for direct contact with the face for treatment. The Looper device consists of an applicator and charging base. An applicator is a hand-held unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The charging base charging for the applicator. And there is no external data connection capability (e.g., through USB, Ethernet, WiFi, Bluetooth, etc.) for the device. There are two keys: the PHOTON key and the SONIC key. The PHOTON is to select red light and the Sonic is to select the SONIC mode and adjust the sonic. Both keys can turn on/off the device.
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    K Number
    K191938
    Device Name
    FitRelief TENS&EMS Wireless Device
    Manufacturer
    Heat In A Click LLC.
    Date Cleared
    2020-08-28

    (406 days)

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

    Heat In A Click LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K150308
    Device Name
    Palm TENS
    Manufacturer
    HEAT IN A CLICK LLC
    Date Cleared
    2015-10-20

    (253 days)

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

    HEAT IN A CLICK LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Palm TENS is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    Not Found
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