BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GW-3045-S-BT

    Reg #: 2424387 · FEI: 2424387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    111
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIO COMPRESSION SYSTEMS, INC.
    Registration Number
    2424387
    FEI Number
    2424387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    120 WEST COMMERCIAL AVE.
    City
    MOONACHIE
    State
    NJ
    ZIP
    07074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210417

    Owner / Operator

    Firm Name
    Bio Compression Systems, Inc
    Operator Number
    2424387
    Address
    120 West Commercial Ave, --
    City
    Moonachie
    State
    NJ
    Postal Code
    07074
    Country
    US
    Correspondent
    Marc L Somelofski

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    GW-3045-S-BT GV-3010-M-R Elite 8 Bio Vest - Medium Right SC-2008-DL Sequential Circulator GN8-3045-L 8-Chamber Leg Sleeve - Large Narrow GBA-3045-L-R Bio Abdominal - Large Right leg GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right A8-3045-L 8-Chamber Leg Sleeve - Large Adjustable G8-3035-SH-L-R 8-Chamber Arm & Shoulder Sleeve - Large Right G8-3035-SH-M-L-BT GN8-3045-M-BT GN-3045-S-BT GS-3045-S 4-Chamber Leg Sleeve - Small GN8-3045-L-BT GW8-3045-M 8-Chamber Leg Sleeve - Medium Wide GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left GV-3010-S-2 Elite 8 Vest with Bilateral Arms - Small GW-3045-M 4-Chamber Leg Sleeve - Medium GS-3045-L-BT GWA8-3045-L 8-Chamber Leg Sleeve - Wide Adjustable Large GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable SC-4008-DL Sequential Circulator SC-2004-DL-BT BioTab Sequential Circulator GN-3045-M-BT GV-3010-L-L Elite 8 Bio Vest - Large Left SC-4008-DL-BT BioTab Sequential Circulator GWA8-3045-S 8-Chamber Leg Sleeve - Wide Adjustable Small GS-3035-SH-M-R-BT GV-3010-S-L Elite 8 Bio Vest - Small Left GV-3010-M-R-BT GW-3045-L 4-Chamber Leg Sleeve - Large GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half GW-3045-S 4-Chamber Leg Sleeve - Small GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GBA-3045-L-L Bio Abdominal - Large Left leg GS-3045-M-BT A8-3045-S 8-Chamber Leg Sleeve - Small Adjustable GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left GW8-3045-S-BT G8-3045-M-BT GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small GV-3000-8C 8-Chamber Vest GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right G8-3035-SH-M-L 8-Chamber Arm & Shoulder Sleeve - Medium Left G8-3045-L-BT GBA-3045-S-R Bio Abdominal - Small Right leg GXWA-3045-BT GS-3045-H 4-Chamber Leg Sleeve - Half GW-3045-L-BT GS-3035-L 4-Chamber Arm Sleeve - Large G8-3035-SH-S-L 8-Chamber Arm & Shoulder Sleeve - Small Left GBA-3045-L-2 Bio Pants - Large G8-3035-SH-L-L 8-Chamber Arm & Shoulder Sleeve - Large Left G8-3035-M 8-Chamber Arm Sleeve - Medium GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small GXW8-3045 8-Chamber Leg Sleeve - Extra Wide GXW-3045 4-Chamber Leg Sleeve - Extra Wide SC-2004-DL Sequential Circulator GV-3010-L-2 Elite 8 Vest with Bilateral Arms - Large GN8-3045-S 8-Chamber Leg Sleeve - Small Narrow GV-3000 4-Chamber Vest G8-3045-M 8-Chamber Leg Sleeve - Medium GBA-3045-S-L Bio Abdominal - Small Left leg GV-3010-M-L Elite 8 Bio Vest - Medium Left GW8-3045-M-BT G8-3035-SH-M-R-BT SC-4004-DL Sequential Circulator G8-3035-L 8-Chamber Arm Sleeve - Large GBA-3045-M-2 Bio Pants - Medium G8-3035-S 8-Chamber Arm Sleeve - Small GBA-3045-M-L Bio Abdominal - Medium Left leg A8-3045-M 8-Chamber Leg Sleeve - Medium Adjustable GS-3045-S-BT G8-3035-SH-S-R 8-Chamber Arm & Shoulder Sleeve - Small Right GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium GW8-3045-S 8-Chamber Leg Sleeve - Small Wide GBA-3045-S-2 Bio Pants - Small GV-3010-M-L-BT GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half GS-3035-M 4-Chamber Arm Sleeve - Medium GXW-3045-BT GN8-3045-M 8-Chamber Leg Sleeve - Medium Narrow G8-3045-S 8-Chamber Leg Sleeve - Small GW8-3045-L 8-Chamber Leg Sleeve - Large Wide GS-3035-SH-M-L-BT GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium GS-3045-M 4-Chamber Leg Sleeve - Medium GV-3010-S-R Elite 8 Bio Vest - Small Right G8-3045-S-BT GV-3010-M-2 Elite 8 Vest with Bilateral Arms - Medium GS-3045-L 4-Chamber Leg Sleeve - Large GBA-3045-M-R Bio Abdominal - Medium Right leg G8-3045-L 8-Chamber Leg Sleeve - Large GS-3035-M-BT GXWA8-3045-BT GS-3045-H-BT G8-3035-SH-M-R 8-Chamber Arm & Shoulder Sleeve - Medium Right GW-3045-H 4-Chamber Leg Sleeve - Half Wide GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow GXW8-3045-BT GXWA8-3045 8-Chamber Leg Sleeve - Extra Wide Adjustable GW-3045-M-BT GN-3045-L 4-Chamber Leg Sleeve - Large Narrow GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right GN-3045-L-BT GW8-3045-L-BT GWA8-3045-M 8-Chamber Leg Sleeve - Wide Adjustable Medium GS-3035-S 4-Chamber Arm Sleeve - Small GV-3010-L-R Elite 8 Bio Vest - Large Right

    Establishment Types

    Manufacture Medical Device