BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Pulse Rx 2.0, Pulse Pro Rx 2.0

    K Number: K183328 · Decision Dec 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    9
    Review Days
    21

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    Basic Information

    Device Name
    Pulse Rx 2.0, Pulse Pro Rx 2.0
    K Number
    K183328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NormaTec Industries, LP
    Date Received
    November 30, 2018
    Decision Date
    December 21, 2018
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by NormaTec Industries, LP

    K Number Device Name
    K251905 Normatec Elite Hip
    K240122 Normatec Elite
    K221666 Normatec Go
    K220217 Normatec 3
    K183169 Pulse 2.0, Pulse Pro 2.0
    K161346 NormaTec PCD-T and PCD-B
    K160608 NormaTec Pulse and NormaTec Pulse Pro
    K112890 NORMATEC MVP