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510(k) Data Aggregation

    K Number
    K212155
    Device Name
    TheraFace LED
    Manufacturer
    Theragun, Inc.
    Date Cleared
    2021-12-21

    (162 days)

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

    Theragun, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device can work in multiple function modes as following with different indication for use: 1) The red light is intended to treat periorbital wrinkles. 2) The blue light is intended to treat mild to moderate inflammatory acne. 3) The Red + IR is intended to treat periorbital wrinkles.
    Device Description
    The TheraFace LED device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm&633 ± 10 nm), or in the blue light region of the spectrum(415±10nm). The TheraFace LED device consists of a main control unit and its attachment applicators for the LED irradiation ring, which can be controlled by the device control button. The device is powered by one internal lithium rechargeable battery which can be charged by an external batterv charger. Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is adjustable to one wavelength with a narrow spectral bandwidth in red light. It provides narrow bands of red-light energy and is intended to treat periorbital 633±10nm. wrinkles. Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is adjustable to one wavelength with a narrow spectral bandwidth in 415 ±10nm. It provides narrow bands of blue light energy to facial skin, and is intended to treat mild to moderate inflammatory acne. Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm) and IR (830 nm) spectrum on facial skin. It is intended to treat periorbital wrinkles.
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    K Number
    K211745
    Device Name
    RecoveryAir PRO
    Manufacturer
    Theragun, Inc.
    Date Cleared
    2021-10-04

    (119 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Theragun, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The Console (Pressure control unit) supplies air at a regulated pressure to a compression garment worn over the area to be treated. The console contains a compressor which generates the air pressure, valves which control the outlet air, user control panel and firmware which controls the pressure and treatment cycle. The pressure control unit is powered by external DC Power Adapter, plugged into a wall electrical outlet or by a recharqeable battery which can operate the device for more than four hours. The battery is located inside the Console and can be charged while the device operates from a wall electrical outlet. The Prong Plug is used as a dummy hose plug for sealing the second air outlet to prevent air escape when the other outlet is connected to the pressure garment. The Medical grade DC Power Adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 12 VDC 3A to the Console. The DC power adaptor is also used for charging the Battery. The Battery Pack is located inside the Console's enclosure is used as backup power. When Battery is fully charged it can power the Console for more than four (4) hours. The Battery may be charged during normal operation of the console. The Battery charging time is up to 8 hours. Smart-phone application uses low power Bluetooth wireless to communicate with the Console. The application enables modifying, storage and display of the device's treatment parameters, and start/stop treatment via Bluetooth communication, similar to reference device (K190493).
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    K Number
    K212238
    Device Name
    TheraFace Microcurrent
    Manufacturer
    Theragun, Inc.
    Date Cleared
    2021-09-29

    (72 days)

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

    Theragun, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheraFace microcurrent is a hand-held device for over-the-counter aesthetic purposes . The TheraFace microcurrent is indicated for facial stimulation.
    Device Description
    The TheraFace microcurrent device consist of main control unit and its attachment applicators for microcurrent output which can be control by the device control button or APP in cell phone via Bluetooth connection. The device powered by one internal lithium rechargeable battery which can be charged by external battery charger. The device has the electrode contractors for facial stimulation by applying an electrical micro current to face skin. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 3 levels of output intensity, which can be adjusted by user. The low-level electrical current pulse goes through the face muscle and cause face muscle contraction for facial stimulation.
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