FDA.reportPublic FDA data

Lower-limb orthosis ankle/foot component

Definition
A non-powered prefabricated (non-customized) component of an externally applied and wearable lower-limb appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct deformities/injuries (e.g., paralysis) or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It is intended to provide motion control functionality through a media-free mechanical resistance mechanism [i.e., spring-actuation with no fluid or gas operating media]. This is a reusable device.
GUDID devices
105
Last updated
2023-02-16 10:06:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10609271000701Health Design Tall Leg WalkerDARCO INTERNATIONAL, INC.HD-LWL-MM02023-02-08
10609271000732Health Design Tall Leg WalkerDARCO INTERNATIONAL, INC.HD-LWL-MM32023-02-08
10609271000749Health Design Tall Leg WalkerDARCO INTERNATIONAL, INC.HD-LWL-MM42023-02-08
10609271000800Health Design Ankle Leg WalkerDARCO INTERNATIONAL, INC.HD-LWS-MM02023-02-08
10609271000831Health Design Ankle Leg WalkerDARCO INTERNATIONAL, INC.HD-LWS-MM32023-02-08
20609271000715Health Design Tall Leg WalkerDARCO INTERNATIONAL, INC.HD-LWL-MM12023-02-08
20609271000722Health Design Tall Leg WalkerDARCO INTERNATIONAL, INC.HD-LWL-MM22023-02-08
20609271000814Health Design Ankle Leg WalkerDARCO INTERNATIONAL, INC.HD-LWS-MM12023-02-08
20609271000821Health Design Ankle Leg WalkerDARCO INTERNATIONAL, INC.HD-LWS-MM22023-02-08
20609271000845Health Design Ankle Leg WalkerDARCO INTERNATIONAL, INC.HD-LWS-MM42023-02-08
10609271080604BUCKS TRACTION w/LINERDARCO INTERNATIONAL, INC.872-0012-102023-02-08
10609271139159DARCO® Body Armor® WalkerDARCO INTERNATIONAL, INC.BAW12023-02-08
10609271139357DARCO® Body Armor® WalkerDARCO INTERNATIONAL, INC.BAW32023-02-08
10609271149226DARCO® Body Armor® Walker linerDARCO INTERNATIONAL, INC.BAWL2G2023-02-08
20609271139255DARCO® Body Armor® WalkerDARCO INTERNATIONAL, INC.BAW22023-02-08
20609271149124DARCO® Body Armor® Walker linerDARCO INTERNATIONAL, INC.BAWL1G2023-02-08
20609271149322DARCO® Body Armor® Walker linerDARCO INTERNATIONAL, INC.BAWL3G2023-02-08
00609271242708DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M1-L2023-02-08
00609271242715DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M1-R2023-02-08
00609271242722DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M2-L2023-02-08
00609271242739DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M2-R2023-02-08
00609271242746DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M3-L2023-02-08
00609271242753DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M3-R2023-02-08
00609271242760DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M4-L2023-02-08
00609271242777DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-M4-R2023-02-08
00609271242807DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-W1-L2023-02-08
00609271242814DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-W1-R2023-02-08
00609271242821DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-W2-L2023-02-08
00609271242838DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-W2-R2023-02-08
00609271242845DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-W3-L2023-02-08
00609271242852DARCO® Relief Insert™ WalkerDarco (Europe) GmbHRIW-W3-R2023-02-08
10609271169156DARCO® Body Armor® WalkerDARCO INTERNATIONAL, INC.BAWS12023-02-08
10609271169255DARCO® Body Armor® WalkerDARCO INTERNATIONAL, INC.BAWS22023-02-08
10609271169354DARCO® Body Armor® WalkerDARCO INTERNATIONAL, INC.BAWS32023-02-08
10609271245171DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS1-110-12023-02-08
10609271245188DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS1-90-12023-02-08
10609271245270DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS2-110-12023-02-08
10609271245287DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS2-90-12023-02-08
10609271245294DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS2-90-P12023-02-08
20609271245192DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS1-90-P12023-02-08
20609271245376DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS3-110-12023-02-08
10609271245386DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS3-90-12023-02-08
10609271245393DARCO® Posterior SplintDARCO INTERNATIONAL, INC.PS3-90-P12023-02-08
10609271289052DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BAT02023-02-08
10609271289151DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BAT12023-02-08
10609271289359DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BAT32023-02-08
10609271289458DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BAT42023-02-08
20609271289257DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BAT22023-02-08
10609271299051DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BATS02023-02-08
10609271299457DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BATS42023-02-08
10609271309125DARCO® Body Armor® Walker linerDARCO INTERNATIONAL, INC.BAWSL1G2023-02-08
10609271489100HED-LOC™DARCO INTERNATIONAL, INC.HL-1122023-02-08
20609271299157DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BATS12023-02-08
20609271299256DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BATS22023-02-08
20609271299355DARCO® Body Armor® Walker IIDARCO INTERNATIONAL, INC.BATS32023-02-08
20609271309221DARCO® Body Armor® Walker linerDARCO INTERNATIONAL, INC.BAWSL2G2023-02-08
20609271309320DARCO® Body Armor® Walker linerDARCO INTERNATIONAL, INC.BAWSL3G2023-02-08
00609271779051DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXL02023-02-08
00609271779150DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXL12023-02-08
00609271779259DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXL22023-02-08
00609271779358DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXL32023-02-08
00609271779457DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXL42023-02-08
00609271789050DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXSL02023-02-08
00609271789159DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXSL12023-02-08
00609271789258DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXSL22023-02-08
00609271789357DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXSL32023-02-08
00609271789456DARCO® FXPro Walker LinerDARCO INTERNATIONAL, INC.FXSL42023-02-08
10609271759050DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FX02023-02-08
10609271759159DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FX12023-02-08
10609271759357DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FX32023-02-08
10609271769059DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FXS02023-02-08
10609271769257DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FXS22023-02-08
20609271759255DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FX22023-02-08
20609271759453DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FX42023-02-08
20609271769155DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FXS12023-02-08
20609271769353DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FXS32023-02-08
20609271769452DARCO® FX Pro™ WalkerDARCO INTERNATIONAL, INC.FXS42023-02-08
14251853900174DARCO® Relief Insert™ Walker CustomizedDARCO INTERNATIONAL, INC.RIW1C-12023-02-08
14251853900181DARCO® Relief Insert™ Walker CustomizedDARCO INTERNATIONAL, INC.RIW1C-22023-02-08
14251853900198DARCO® Relief Insert™ Walker CustomizedDARCO INTERNATIONAL, INC.RIW1C-32023-02-08