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510(k) Data Aggregation

    K Number
    K213097
    Device Name
    Armory Motion
    Manufacturer
    Pain Management Technologies, Inc.
    Date Cleared
    2022-06-10

    (259 days)

    Product Code
    ILO, IRP
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pain Management Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.
    Device Description
    Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy. The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee. The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy. The insulated container is filled with ice and water by the user. The water circulates through the cold compression pad to deliver cold therapy to the application site. The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.
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