BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Omnispec ED1000

    K Number: K210166 · Decision Jan 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    783
    Registration Numbers
    783
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    736

    Basic Information

    Device Name
    Omnispec ED1000
    K Number
    K210166
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medispec Ltd.
    Date Received
    January 21, 2021
    Decision Date
    January 27, 2023
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

    Similar 510(k) Clearances

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

    VMAT PRO

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ShockPhysio Mobile (model SW3200 Basic)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTL-094

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OW100S (model OW100S-US)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DolorClast Radial

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OrthoGold 100

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all