BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TOP SHELF MANUFACTURING, LLC

    Reg #: 3003890514 · FEI: 3003890514 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    40
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    TOP SHELF MANUFACTURING, LLC
    Registration Number
    3003890514
    FEI Number
    3003890514
    Status
    Active
    Expiry Year
    2026
    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
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Pack, Hot Or Cold, Reusable IME
    Crutch IPR
    Orthosis, Limb Brace IQI
    Table And Attachments, Operating-Room BWN
    Component, Traction, Non-Invasive KQZ
    Joint, Ankle, External Brace ITW
    Components, Exercise IOD
    Apparatus, Traction, Non-Powered HST
    Joint, Knee, External Brace ITQ
    Dermal Cooling Pack/Vacuum/Massager OOK
    Joint, Hip, External Brace ITS
    Orthosis, Cervical IQK
    Splint, Hand, And Components ILH
    Sling, Arm ILI
    Orthosis, Lumbo-Sacral IPY
    Walker, Mechanical ITJ
    Binder, Abdominal FSD
    Cover, Limb IPM
    Shoe, Cast IPG
    Pack, Hot Or Cold, Water Circulating ILO
    Goniometer, Ac-Powered KQX

    Proprietary Names

    Toe Repair Kit Cold Gel Wrap Crutch TR CC Post-op Knee, Over The Shoulder Humeral Fracture Brace, TR CC w/Covered Hinge TeleRange Post-op Brace, TR Post-op Brace, TR Rapid Fit Post-op Brace, TR Rehab Post-op Brace, AB/EX Shoulder Strap TeleRange 2 Post-op Brace, Posterior Night Splint, ROM Universal Post-op Knee, Anchor Shoulder Brace Bader Leg Holder Compact Sleeve, Traction Sleeve, Standard Sleeve, Standard Sleeve w/Strap Lunar Walker, Lunar Air Walker, Horizon Walker, Air Horizon Walker, Air/Gel Ankle Stirrup, Air Ankle Stirrup 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 Hinged Ankle Stabilizer, Hinged Gauntlet Pro, Gauntlet Pro Cinch Ankle Stabilizer, Solar Air Walker Ankle CPM Pads, SYSTEM Kit, TEAM Kit, FLEX Kit Shoulder Holder Under Brace Sleeve, Thigh Sleeve, Calf Sleeve, Elbow Sleeve, Tendonitis Strap, Knee Sleeve, Patella Stabilizer Adjustable Patella Buttress w/Contour Hinge, Adjustable Patella Buttress, Economy Hinged Knee, Sports Cover RelOAd Knee Brace, Lateral Patella Stabilizer, Tri-Panel Knee Immobilizer, Knee Immobilizer, Protex Elbow Brace Target OA Knee Brace, TeleRange Post-op Elbow, Knee Tube Hinged Knee w/Covered Hinge, Hinged Lateral Patella Stabilizer Lateral Patella Stabilizer w/Contour Hinge, Hinged Knee Plus Half Wrap, The Crusader, Knight Lite Hinged Knee Plus, Hinged Knee, Revolution Knee Brace, The Knight Brace, Protex Elbow Brace, The Knight OA Hip ROM Post-Op Brace Tracy Collar, Cervical Collar Suede Laceup Wrist Support, I-Fit Wrist Forearm Support, Univ Thumb Lacer, Thumb Lacer, Univ Gel Wrist CMC Thumb Splint, Wrist Sleeve, Univ Thumb Splint, Univ Wrist Laceup Forearm Support, Pro Wrap Wrist I-Fit Wrist Support, I-Fit Wrist Supp w/Thumb, Suede Looplock Wrist Support, Univ Laceup Wrist Support Shoulder Immobilizer Univ, High Hand Sling, Stable Sling3 ER, Open Stable Sling, Open Stable Sling SPS, Stable Sling, Stable Sling Universe, Stable Sling 2, The Remedy, The Remedy 2, Arm Sling, Arm Sling w/Padded Strap Arm Sling with Open Pocket, Arm Sling w/Padded Strap, Shoulder Immobilizer w/Web Strap, Shoulder Wrap Shoulder Immob. Sling w/Foam Strap, Shoulder Wrap Sleeve, Conformer Shoulder Immob. Arm Sling with Pad, Stable Sling Only, Stable Sling3 Only, SPD Shoulder Positioning Device, Stable Sling 3 Universe Boa Back Brace 75 Degree, Boa Back Brace Lite, Boa Back Brace w/Slim Panel XTR, Chairback, BOA Universe Boa Back Brace Low Pro, Boa Back Brace Regular, Sacroiliac Brace, TLSO Brace, Industrial Back Brace Walker 9" Universal Abdominal Binder The Protector Post-op Shoe Rigid, Post op Shoe Flex, Post-op Shoe Square Toe, Cast Boot Rocker, Forefoot Offloading Shoe Sierra Cold Therapy System, Sierra Cold Therapy System w/Multiuse Pad, Sierra Cold Therapy System w/Shoulder Pad Sierra Cold Therapy System w/Knee Pad, Sierra Cold Therapy System Shoulder Pad Sierra Cold Therapy System Multiuse Pad, Sierra Cold Therapy System Knee Pad

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)