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

    MOISTURESTAY (REVLON)

    K Number: K022626 · Decision Oct 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    83

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MOISTURESTAY (REVLON)
    K Number
    K022626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5110
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Raymond Industrial, Ltd.
    Date Received
    August 7, 2002
    Decision Date
    October 29, 2002
    Product Code
    IMC
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMC Bath, Paraffin

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IMC), ordered by most recent decision date.

    REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SOFTIQUE, MODEL GI 11001

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PARAMED PARAFFIN WARMER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PARA-CARE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Raymond Industrial, Ltd.

    K Number Device Name
    K912822 PERSONAL BODY MASSAGER, MODELS 1605 & 1606