BEUDAMED
    Product Code: PFW FDA class 2 21 CFR 890.5300

    Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

    Physical Medicine

    The Stationary Ultrasonic Diathermy Device for Use in Applying Therapeutic Deep Heat is a physical medicine device that uses stationary applicators to enable hands-free operation for delivering therapeutic ultrasonic heat to deep tissue. It is an FDA Class 2 device regulated under 21 CFR 890.5300, requiring 510(k) premarket notification, within the Physical Medicine (PM) specialty. The product code is PFW, and it is eligible for third-party review. This device is not implantable and does not sustain life.

    View on FDA
    510(k)s
    9
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    5
    Years Active
    18

    Research product code PFW in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PFW
    Device Class
    FDA class 2
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    1

    Device Characteristics

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

    Definition

    Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K260076 SAM 3.0 Multi-Hour Continuous Ultrasound Device
    K233210 sam CS Long Duration Ultrasound Device
    K223019 sam 2.0 Long Ultrasound Device
    K221210 PainShield MD PLUS
    K211513 sam X1 Long Duration Ultrasound Device
    K191568 sam 2.0 Long Duration Ultrasound System
    K130978 ZTX ULTRASONIC DIATHERMY DEVICE
    K081075 PAINSHIELD MD
    K072256 HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.