BEUDAMED
    Product Code: LPQ FDA class 3

    Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

    Unknown

    This device is an ultrasound and muscle stimulator intended for uses other than applying therapeutic deep heat, which may include neuromuscular stimulation or other therapeutic modalities not involving deep tissue heating applications. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) given the potential risks of electrical stimulation and ultrasound energy delivery in unverified applications. The product code is LPQ; no regulation number or specific medical specialty is listed for this entry. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    LPQ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.