BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AeroDVx Gradient Compression System

    Reg #: 3008773774 · FEI: 3008773774 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SUN-SCIENTIFIC INC.
    Registration Number
    3008773774
    FEI Number
    3008773774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    145 Palisade St, Suite LL11
    City
    Dobbs Ferry
    State
    NY
    ZIP
    10522
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183349

    Owner / Operator

    Firm Name
    Sun-Scientific Inc.
    Operator Number
    10034866
    Address
    145 Palisade Street
    City
    Dobbs Ferry
    State
    NY
    Postal Code
    10522
    Country
    US
    Correspondent
    Sundaram Ravikumar

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    AeroDVx Gradient Compression System AeroDVx™, Medium/Large Flex Bilateral AeroDVx™, Extra Large Flex Bilateral AeroDVx ™Small, Unilateral, Flex AeroDVx™ Medium, Bilateral, Flex AeroDVx™, Small/Medium Flex Bilateral AeroDVx™, Small Flex Bilateral AeroDVx ™Small, Bilateral, Flex AeroDVx™, Large, Unilateral, Flex AeroDVx™, Extra Large, Bilateral, Flex AeroDVx™, Large, Bilateral, Flex AeroDVx™, Extra Large, Unilateral, Flex AeroDVx™ Medium, Unilateral, Flex

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility