BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small

    Reg #: 2424387 · FEI: 2424387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    86
    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
    K150953

    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

    GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small GS-3045-H 4-Chamber Leg Sleeve - Half GBA-3045-S-L Bio Abdominal - Small Left leg GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small GS-3035-SH/L 4-Chamber Arm & Shoulder Sleeve - Large G8-3035-SH-L-L 8-Chamber Arm & Shoulder Sleeve - Large Left GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right GWA8-3045-S 8-Chamber Leg Sleeve - Wide Adjustable Small SC-2004-OC-230 Sequential Circulator GW8-3045-M 8-Chamber Leg Sleeve - Medium Wide GWA8-3045-L 8-Chamber Leg Sleeve - Wide Adjustable Large GV-3000 4-Chamber Vest GW-3045-H 4-Chamber Leg Sleeve - Half Wide GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GV-3000-8C 8-Chamber Vest GXW8-3045 8-Chamber Leg Sleeve - Extra Wide GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow G8-3035-SH-M-R 8-Chamber Arm & Shoulder Sleeve - Medium Right G8-3035-L 8-Chamber Arm Sleeve - Large G8-3035-SH-M-L 8-Chamber Arm & Shoulder Sleeve - Medium Left G8-3045-S 8-Chamber Leg Sleeve - Small GBA-3045-S-R Bio Abdominal - Small Right leg GN8-3045-S 8-Chamber Leg Sleeve - Small Narrow GN8-3045-L 8-Chamber Leg Sleeve - Large Narrow GXW-3045 4-Chamber Leg Sleeve - Extra Wide A8-3045-S 8-Chamber Leg Sleeve - Small Adjustable GV-3010-M-L Elite 8 Bio Vest - Medium Left G8-3035-SH-S-L 8-Chamber Arm & Shoulder Sleeve - Small Left GS-3045-M 4-Chamber Leg Sleeve - Medium G8-3035-M 8-Chamber Arm Sleeve - Medium SC-2004-OC Sequential Circulator GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half GW-3045-L 4-Chamber Leg Sleeve - Large GV-3010-L-2 Elite 8 Vest with Bilateral Arms - Large GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium GS-3035-L 4-Chamber Arm Sleeve - Large GV-3010-L-R Elite 8 Bio Vest - Large Right GW-3045-S 4-Chamber Leg Sleeve - Small GV-3010-M-R Elite 8 Bio Vest - Medium Right GS-3035-M 4-Chamber Arm Sleeve - Medium GBA-3045-M-R Bio Abdominal - Medium Right leg GBA-3045-M-2 Bio Pants - Medium GN8-3045-M 8-Chamber Leg Sleeve - Medium Narrow GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium SC-2008-OC Sequential Circulator GW8-3045-S 8-Chamber Leg Sleeve - Small Wide GBA-3045-L-L Bio Abdominal - Large Left leg G8-3035-SH/L 8-Chamber Arm & Shoulder Sleeve - Large GV-3010-S-L Elite 8 Bio Vest - Small Left GW-3045-M 4-Chamber Leg Sleeve - Medium GS-3045-L 4-Chamber Leg Sleeve - Large GS-3045-S 4-Chamber Leg Sleeve - Small GS-3035-S 4-Chamber Arm Sleeve - Small GS-3035-SH/S 4-Chamber Arm & Shoulder Sleeve - Small G8-3035-SH-S-R 8-Chamber Arm & Shoulder Sleeve - Small Right A8-3045-M 8-Chamber Leg Sleeve - Medium Adjustable GWA8-3045-M 8-Chamber Leg Sleeve - Wide Adjustable Medium GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half GV-3010-L-L Elite 8 Bio Vest - Large Left GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable G8-3035-SH/M 8-Chamber Arm & Shoulder Sleeve - Medium G8-3045-M 8-Chamber Leg Sleeve - Medium GBA-3045-L-2 Bio Pants - Large GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left G8-3035-SH/S 8-Chamber Arm & Shoulder Sleeve - Small GV-3010-M-2 Elite 8 Vest with Bilateral Arms - Medium GV-3010-S-2 Elite 8 Vest with Bilateral Arms - Small GXWA8-3045 8-Chamber Leg Sleeve - Extra Wide Adjustable GBA-3045-S-2 Bio Pants - Small GS-3035-SH/M 4-Chamber Arm & Shoulder Sleeve - Medium G8-3045-L 8-Chamber Leg Sleeve - Large A8-3045-L 8-Chamber Leg Sleeve - Large Adjustable GBA-3045-L-R Bio Abdominal - Large Right leg GV-3010-S-R Elite 8 Bio Vest - Small Right GBA-3045-M-L Bio Abdominal - Medium Left leg GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left SC-2008-OC-230 Sequential Circulator G8-3035-SH-L-R 8-Chamber Arm & Shoulder Sleeve - Large Right GW8-3045-L 8-Chamber Leg Sleeve - Large Wide GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right GN-3045-L 4-Chamber Leg Sleeve - Large Narrow G8-3035-S 8-Chamber Arm Sleeve - Small

    Establishment Types

    Manufacture Medical Device