Home GUDID 00819567017907 Comfytopia
Primary DI 00819567017907
Brand Comfytopia
Company Comfytopia, Inc.
Model KS10
Device description BRACOO KS10 Knee Fulcrum Wrap Comfort fit Gray
Published 2025-07-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name ITQ Joint, Knee, External Brace
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITQ Joint, Knee, External Brace Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00819567017907 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00819567017907 00819567017907 819567017907 0819567017907
GMDN Terms# Term, Definition table Term Definition Multiple-joint lower limb orthosis A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of multiple joints of the lower body which will include the knee (e.g., hip and knee, knee and ankle). The device is typically adjustable and articulating. This is a reusable device.
Regulatory Flags# DUNS number 003944628 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Contains natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810179882389 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882396 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882419 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882426 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882488 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882495 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882501 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882624 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810179882631 Copperfit Ideavillage Products Corp ITQ 2026-10-01 00810226441538 Vive VIVE HEALTH LLC ITQ 2026-08-03 00049696508377 THERA Plus FOURSTAR GROUP INC. ITQ 2026-06-09 00810178889280 CoreTech VIVE HEALTH LLC ITQ 2026-05-05 00810178889297 CoreTech VIVE HEALTH LLC ITQ 2026-05-05 00810178889303 CoreTech VIVE HEALTH LLC ITQ 2026-05-05 00810178889310 CoreTech VIVE HEALTH LLC ITQ 2026-05-05 00810178889327 CoreTech VIVE HEALTH LLC ITQ 2026-05-05 00057475210434 BIOS Living Thermor Ltd ITQ 2023-03-31 00609271200135 16'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200159 16'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200173 16'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200180 16'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200197 16'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200333 20'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200357 20'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200371 20'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200388 20'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271200395 20'' DLX POST-OP KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271210509 20'' DLX 3-PANEL KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271210608 20'' DLX 3-PANEL KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08 00609271210806 20'' DLX 3-PANEL KNEE IMMOB DARCO INTERNATIONAL, INC. ITQ 2023-02-08