FDA.reportPublic FDA data

Pressure-management insole, prefabricated

Definition
A prefabricated (non-customized) device intended to be worn against the feet to reduce peak foot pressures and improve pedal circulation in a patient who has, or who is at risk of developing, peripheral vascular disease (PVD) or diabetic foot disease. It typically contains a gel-filled cushion intended to distribute force to facilitate improved blood flow within the foot. This is a reusable device.
GUDID devices
189
Last updated
2026-07-30 21:31:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00609271999336Aircore™ InsoleDARCO INTERNATIONAL, INC.ACI02026-07-20
00609271999343Aircore™ InsoleDARCO INTERNATIONAL, INC.ACI12026-07-20
00609271999374Aircore™ InsoleDARCO INTERNATIONAL, INC.ACI42026-07-20
00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.ACI52026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.ACI22026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.ACI32026-07-20
00609271279179DARCO® Wound Care Shoe System™ InsolesDarco (Europe) GmbHWCI02023-02-08
00609271279186DARCO® Wound Care Shoe System™ InsolesDarco (Europe) GmbHWCI12023-02-08
00609271279193DARCO® Wound Care Shoe System™ InsolesDarco (Europe) GmbHWCI22023-02-08
00609271279292DARCO® Wound Care Shoe System™ InsolesDarco (Europe) GmbHWCI32023-02-08
00609271279391DARCO® Wound Care Shoe System™ InsolesDarco (Europe) GmbHWCI42023-02-08
00609271279490DARCO® Wound Care Shoe System™ InsolesDarco (Europe) GmbHWCI52023-02-08
00609271279704DARCO® WCS™ / WCS™ Light InsolesDarco (Europe) GmbHWCI5/R2023-02-08
00609271279995DARCO® Wound Care Shoe System™ InsolesDarco (Europe) GmbHWCI72023-02-08
00609271309012DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-STL02023-02-08
00609271309111DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-STL12023-02-08
00609271309210DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-STL22023-02-08
00609271309319DARCO® PegAssist® InsoleDARCO INTERNATIONAL, INC.PAS-STL32023-02-08
00609271309418DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-STL42023-02-08
00609271319059DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS02023-02-08
00609271319158DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS12023-02-08
00609271319257DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS22023-02-08
00609271319356DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS32023-02-08
00609271319455DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS42023-02-08
00609271330153DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-M12023-02-08
00609271330252DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-M22023-02-08
00609271330351DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-M32023-02-08
00609271330450DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-M42023-02-08
00609271333154DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-W12023-02-08
00609271333253DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-W22023-02-08
00609271333352DARCO® PegAssist™ InsoleDARCO INTERNATIONAL, INC.PAS-W32023-02-08
00609271909090DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PQ02023-02-08
00609271909199DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PQ12023-02-08
00609271909298DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PQ22023-02-08
00609271909397DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PQ32023-02-08
00609271909496DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PQ42023-02-08
00609271909595DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PW02023-02-08
00609271909694DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PW12023-02-08
00609271909793DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PW22023-02-08
00609271909892DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PW32023-02-08
00609271909991DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PW42023-02-08
00609271920194DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PTQM12023-02-08
00609271920293DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PTQM22023-02-08
00609271920392DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PTQM32023-02-08
00609271920491DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PTQM42023-02-08
00609271923195DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PTQW12023-02-08
00609271923294DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PTQW22023-02-08
00609271923393DARCO® Peg-Assist™ Off-loading InsoleDARCO INTERNATIONAL, INC.PTQW32023-02-08
00609271989603Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0602026-01-07
00609271989610Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0702026-01-07
00609271989627Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0752026-01-07
00609271989634Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0802026-01-07
00609271989658Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0902026-01-07
00609271989665Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0952026-01-07
00609271989672Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1002026-01-07
00609271989689Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1052026-01-07
00609271989696Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1102026-01-07
00609271989702Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1152026-01-07
00609271989719Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1202026-01-07
00609271989726Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1252026-01-07
00609271989733Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1302026-01-07
00609271989740Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1352026-01-07
00609271989757Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1452026-01-07
00609271989764Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1552026-01-07
00609271989641Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0852026-01-07
20609271989607Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0602026-01-07
20609271989614Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0702026-01-07
20609271989621Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0752026-01-07
20609271989638Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0802026-01-07
20609271989652Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0902026-01-07
20609271989669Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP0952026-01-07
20609271989676Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1002026-01-07
20609271989683Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1052026-01-07
20609271989690Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1102026-01-07
20609271989706Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1152026-01-07
20609271989713Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1202026-01-07
20609271989720Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1252026-01-07
20609271989737Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1302026-01-07
20609271989744Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1352026-01-07
20609271989751Aircore™ InsoleDARCO INTERNATIONAL, INC.ACIP1452026-01-07