FDA.reportPublic FDA data

Orthotic shoe, non-customized

Definition
A prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.
GUDID devices
657
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00609271000155DARCO® Commodus OpenDarco (Europe) GmbHCO02023-02-08
00609271000162DARCO® Commodus OpenDarco (Europe) GmbHCO12023-02-08
00609271000179DARCO® Commodus OpenDarco (Europe) GmbHCO22023-02-08
00609271000186DARCO® Commodus OpenDarco (Europe) GmbHCO32023-02-08
00609271000193DARCO® Commodus OpenDarco (Europe) GmbHCO42023-02-08
00609271000254KERRAPED™ All Purpose BootDarco (Europe) GmbHKP1B2023-02-08
00609271000261KERRAPED™ All Purpose BootDarco (Europe) GmbHKP2B2023-02-08
00609271000278KERRAPED™ All Purpose BootDarco (Europe) GmbHKP3B2023-02-08
00609271000285KERRAPED™ All Purpose BootDarco (Europe) GmbHKP4B2023-02-08
00609271000353KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKPP12023-02-13
00609271000360KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKPP22023-02-13
00609271000377KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKPP32023-02-13
00609271000384KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKPP42023-02-13
00609271000902Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL12023-02-08
00609271000919Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL22023-02-08
00609271000926Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL32023-02-08
00609271000933Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL42023-02-08
00609271000940Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL52023-02-08
00609271000957Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL62023-02-08
00609271000964Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL72023-02-08
00609271000971Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL82023-02-08
00609271000988Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-CL92023-02-08
00609271001008Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ12023-02-08
00609271001015Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ22023-02-08
00609271001022Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ32023-02-08
00609271001039Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ42023-02-08
00609271001046Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ52023-02-08
00609271001053Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ62023-02-08
00609271001060Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ72023-02-08
00609271001077Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-EZ82023-02-08
00609271001107Health Design Forefoot Reliever Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-FR12023-02-08
00609271001114Health Design Forefoot Reliever Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-FR22023-02-08
00609271001121Health Design Forefoot Reliever Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-FR32023-02-08
00609271001138Health Design Forefoot Reliever Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-FR42023-02-08
00609271001145Health Design Forefoot Reliever Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-FR52023-02-08
00609271001305Health Design Posi Wedge Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-PW12023-02-08
00609271001312Health Design Posi Wedge Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-PW22023-02-08
00609271001329Health Design Posi Wedge Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-PW32023-02-08
00609271001336Health Design Posi Wedge Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-PW42023-02-08
00609271001428DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-M12023-02-13
00609271001435DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-M22023-02-13
00609271001442DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-M32023-02-13
00609271001459DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-M42023-02-13
00609271001466DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-W12023-02-13
00609271001473DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-W22023-02-13
00609271001480DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-W32023-02-13
00609271001497DARCO® Relief Dual® PlusDarco (Europe) GmbHRDP-M52023-02-13
00609271001503Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST12023-02-08
00609271001510Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST22023-02-08
00609271001527Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST32023-02-08
00609271001534Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST42023-02-08
00609271001541Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST52023-02-08
00609271001558Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST62023-02-08
00609271001565Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST72023-02-08
00609271001572Health Design Sof Touch Post Op ShoeDARCO INTERNATIONAL, INC.HD-PO-ST82023-02-08
00609271003002DARCO® AllRound Shoe™Darco (Europe) GmbHARS02023-02-08
00609271003019DARCO® AllRound Shoe™Darco (Europe) GmbHARS12023-02-08
00609271003026DARCO® AllRound Shoe™Darco (Europe) GmbHARS22023-02-08
00609271003033DARCO® AllRound Shoe™Darco (Europe) GmbHARS32023-02-08
00609271003040DARCO® AllRound Shoe™Darco (Europe) GmbHARS42023-02-08
00609271003057DARCO® AllRound Shoe™Darco (Europe) GmbHARS52023-02-08
00609271010116DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSM1N2023-02-13
00609271010215DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSM2N2023-02-13
00609271010314DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSM3N2023-02-13
00609271010413DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSM4N2023-02-13
00609271013117DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSW1N2023-02-13
00609271013216DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSW2N2023-02-13
00609271013315DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSW3N2023-02-13
00609271016514DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.MSPN2023-02-13
00609271090156DARCO® Softie™ shoeDARCO INTERNATIONAL, INC.STM1B2023-02-08
00609271090255DARCO® Softie™ shoeDARCO INTERNATIONAL, INC.STM2B2023-02-08
00609271090354DARCO® Softie™ shoeDARCO INTERNATIONAL, INC.STM3B2023-02-08
00609271090453DARCO® Softie™ shoeDARCO INTERNATIONAL, INC.STM4B2023-02-08
00609271093157DARCO® Softie™ shoeDARCO INTERNATIONAL, INC.STW1B2023-02-08
00609271093256DARCO® Softie™ shoeDARCO INTERNATIONAL, INC.STW2B2023-02-08
00609271093355DARCO® Softie™ shoeDARCO INTERNATIONAL, INC.STW3B2023-02-08
00609271119055DARCO® A.P.B.™DARCO INTERNATIONAL, INC.APB0B2023-02-08
00609271119154DARCO® A.P.B.™DARCO INTERNATIONAL, INC.APB1B2023-02-08
00609271119253DARCO® A.P.B.™DARCO INTERNATIONAL, INC.APB2B2023-02-08
00609271119352DARCO® A.P.B.™DARCO INTERNATIONAL, INC.APB3B2023-02-08