BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sunrise Medical (US) LLC

    Reg #: 3019677893 · FEI: 3019677893 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    96
    Establishment Types
    5
    Classifications
    21

    Registration Details

    Registration Name
    Sunrise Medical (US) LLC
    Registration Number
    3019677893
    FEI Number
    3019677893
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    12002 Volunteer Blvd
    City
    Mount Juliet
    State
    TN
    ZIP
    37122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K001491

    Owner / Operator

    Firm Name
    Sunrise Medical (US) LLC
    Operator Number
    9019832
    Address
    12002 Volunteer Blvd
    City
    Mount Juliet
    State
    TN
    Postal Code
    37122
    Country
    US
    Correspondent
    Neeraj Patel

    Products

    Device Name Product Code
    Handrim, Wheelchair IMO
    Aid, Transfer IKX
    Armrest, Wheelchair IML
    Components, Wheelchair KNN
    Walker, Mechanical ITJ
    Support, Head And Trunk, Wheelchair IMS
    Cushion, Flotation KIC
    Wheelchair, Mechanical IOR
    Wheelchair, Powered ITI
    Board, Lap, Wheelchair IMX
    Wheelchair, Standup IPL
    Footrest, Wheelchair IMM
    Holder, Crutch And Cane, Wheelchair IMZ
    Accessories, Wheelchair KNO
    Chair, With Casters INM
    Device, Anti-Tip, Wheelchair IMR
    Adaptor, Hygiene ILS
    Protector, Skin Pressure FMP
    Brake, Extension, Wheelchair IMW
    Belt, Wheelchair IQB
    Cushion, Wheelchair IMP

    Proprietary Names

    Quickie Zippie Magic Mobility LUCI Switch-It Leckey MyWay MyWay+ Whitmyer Jay Octane Octane FX Octane SUB4 Tiga FX Tiga SUB4 Tiga Hilite Veypr SUB4 Quickie Xtender Empulse M90 Quickie Q500 M Quickie Q300 M Quickie Q200 R Quickie Q500 H Quickie Q700-UP M Quickie Q700 M Ride Custom Back Ride Custom Cushion Pre-Sewn Forward Cushion Cover, outer Ride Java Cushion Ride Decaf Java Back BeMe Seating System Dual Pro Joystick In A Can Cool Cube MyGo Seating System Squiggles Seating System CTRL+5 VersaGuide Empulse R20 Switch-It Vigo MyGo Seat Ride Forward Cushion, Inner Ride Java Back Q50 R Carbon X8 Extreme 4x4 VOYAGE MIGHTY LITE STROLLER MyGo Stander Squiggles Seat Horizon Stander Pronestander Freestander Squiggles Stander Squiggles TT Stander Squiggles Plus Stander Totstander Everyday Activity Seat KID KART STROLLER Frontier V6 Frontier V4 RWD Frontier V4 FWD Frontier QXi Sleepform Pal Early Activity System Advance Bath Chair Extreme X8 ZIPPIE GS Magic 360 Zippie TS SR45 Quickie GP Zippie Zone Zippie X'CAPE Empulse R90 Empulse F35 Magic XT4 Magic XT Series XT2 Magic XT2 XT4 XT Series Quickie IRIS Zippie IRIS Quickie QRi Quickie 2 HD Quickie 5R Quickie Nitrum Zippie Sphynx Quickie 2 Lite Quickie Access Quickie M6 Quickie QS5 X Jay Wheelchair Cushions

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device