BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hinged Ankle Stabilizer, Hinged Gauntlet Pro, Gauntlet Pro Cinch Ankle Stabilizer, Solar Air Walker Ankle

    Reg #: 3003890514 · FEI: 3003890514 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TOP SHELF MANUFACTURING, LLC
    Registration Number
    3003890514
    FEI Number
    3003890514
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1851 E. PARADISE ROAD, SUITE A
    City
    Tracy
    State
    CA
    ZIP
    95304
    Country
    US

    Owner / Operator

    Firm Name
    TOP SHELF MANUFACTURING, LLC
    Operator Number
    9054233
    Address
    1851 E. PARADISE RD, SUITE A, --
    City
    Tracy
    State
    CA
    Postal Code
    95304
    Country
    US
    Correspondent
    CRAIG - KOLOSKE

    Products

    Device Name Product Code
    Joint, Ankle, External Brace ITW

    Proprietary Names

    Hinged Ankle Stabilizer, Hinged Gauntlet Pro, Gauntlet Pro Cinch Ankle Stabilizer, Solar Air Walker Ankle Gauntlet Pro Cinch 2 Ankle Stabilizer, Hinged Gauntlet Pro Cinch 2 Ankle Stabilizer, Solar Air Walker Ankle Stabilizer, The Gauntlet Ankle Stabilizer, The Gauntlet Pro Ankle Stabilizer, Hinged Ankle Stabilizer Lunar Walker, Lunar Air Walker, Horizon Walker, Air Horizon Walker, Air/Gel Ankle Stirrup, Air Ankle Stirrup

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device