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510(k) Data Aggregation

    K Number
    K241256
    Device Name
    JetBoots PRO Plus
    Manufacturer
    Therabody, Inc.
    Date Cleared
    2024-08-30

    (116 days)

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

    Therabody, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in people who are in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment. JetBoots PRO Plus is two leg shaped garments, one that acts a Lead and the other a Support boot. Each boot is comprised of a console (pressure control unit), a control panel or support power button, and a compression garment in the shape of a boot. The console contains an air pump (compressor) to generate the air pressure, four valves to control the outlet air, a circuit board with embedded firmware to control the pressure, an internal rechargeable battery, and a charging port. The console is fixed to the bottom of the foot on each compression garment, which allows for easy wearing on and off. Each compression boot has four internal overlapping chambers that can be inflated independently of each other. The device can provide different compression levels in the range from 20mmHg to 100mmHg depending on the user's selection. Hold time is set within the range of 0-10 seconds depending on the preset selected and release time is set by default to 15 seconds. The lead and support JetBoots PRO Plus boots are each powered by an internal rechargeable battery or by an external DC Power Adapter, plugged into a wall electrical outler. The batteries are located inside each console and can be charged while the device operates. A 72W 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 15.0V, 4.8A. The 72W DC power adapter is able to support both boots to work, charge, and work and charge at the same time if using the splitter cable provided. The JetBoots PRO Plus are also capable of providing therapeutic warming via the included Light Emitting Diode (LED) Strips. The LEDs emit an infrared light frequency at 850nm and are provided as an optional treatment modality. They can be utilized for a maximum of 45 minutes, either as a standalone therapy or in tandem with the JetBoots PRO Plus' primary device function, pneumatic compression. Therapeutic warming via infrared LEDs is considered to be an "Other Device Function." The JetBoots PRO Plus also capable of providing therapeutic vibrations via included vibrating pill motors. These are included for an improved user experience and are considered to be an "Other Device Function" that has no impact on the JetBoots PRO Plus' primary device function.
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    K Number
    K230293
    Device Name
    TheraFace Mask
    Manufacturer
    Therabody, Inc.
    Date Cleared
    2023-06-09

    (127 days)

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

    Therabody, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - · Red Light is intended to treat full face wrinkles - · Blue Light is intended to treat mild to moderate inflammatory acne - · Red + Infrared Light is intended to treat full face wrinkles
    Device Description
    The TheraFace Mask 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 Mask device is shaped like a human face and is designed to be "one size fits most." There are two physical buttons located on the mask; one controls the LED function and the other controls the vibration. The 648 LEDs in the device are powered by two internal lithium-ion rechargeable batteries which are charged via USB Type C or A cable with power adaptor. Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is one wavelength with a narrow spectral bandwidth in 633±10nm. red light. lt provides narrow bands of red-light energy to facial skin and is intended to treat full-face wrinkles. Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is 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±10nm) and IR (830 nm±10nm) spectrum on facial skin. lt is intended to treat full face wrinkles. Vibration mode: The device can drive 8 vibration motors around the eyes and 9 vibration motors on the top and back of the head in different vibration speeds. There are 3 different vibration patterns; continuous mode, breathe mode, and wave mode. Vibration is included for general relaxation purposes.
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