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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
    Type
    Traditional
    Panel
    Physical Medicine (PM)
    Reference & Predicate Devices
    K221189,K062532,K211745
    Why did this record match?
    Reference Devices :

    K221189, K062532

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for a medical device called "JetBoots PRO Plus." However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to AI/algorithm performance, as the device is a powered inflatable tube massager with additional functions like infrared LED heat and therapeutic vibrations, not an AI-powered diagnostic or assistive device.

    Therefore, I cannot provide the information requested in the prompt based on the given text.

    The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

    • Indications for Use: (Page 3-4, 5)
    • Technological Characteristics: (Pages 6-8, Table 1, "Comparison in Detail(s)")
    • Performance Comparison: (Pages 9-12, Table 2)
    • Safety Comparison: (Page 13, Table 3)
    • Performance Data (Bench/Non-Clinical Testing): Electrical safety, EMC, biocompatibility, software V&V, temperature range testing, mechanical testing (Page 13-14).

    There is no mention of an algorithm or AI in the context of device performance or clinical studies. The "Software Verification and Validation Testing" section (Page 14) refers to general software lifecycle processes (IEC 62304) for embedded firmware controlling the pressure, not for an AI/ML component.

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