FDA.reportPublic FDA data

Multiple-joint lower limb orthosis

Definition
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.
GUDID devices
110
Last updated
2026-08-08 10:09:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840194499248Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-40012026-03-02
00840194499255Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-41012026-03-02
00840194499262Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-40022026-03-02
00840194499279Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-41022026-03-02
00840194499194Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-30012026-03-02
00840194499200Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-30022026-03-02
00840194499217Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-30032026-03-02
00840194499224Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-30042026-03-02
00840194499231Contracture ManagementORTHOPEDIATRICS CORP.NS-6000-30052026-03-02
04719879642889ComfyHealthComfy Health Group Co., Ltd.FP312025-07-10
04719879646009ComfyHealthComfy Health Group Co., Ltd.KP322025-07-10
00819567011608ComfytopiaComfytopia, Inc.FP302025-07-09
00819567011615ComfytopiaComfytopia, Inc.FP30 2025-07-09
00819567011646ComfytopiaComfytopia, Inc.KP302025-07-09
00819567011660ComfytopiaComfytopia, Inc.FS102025-07-09
00819567017853ComfytopiaComfytopia, Inc.FS102025-07-09
00819567017860ComfytopiaComfytopia, Inc.FS102025-07-09
00819567017877ComfytopiaComfytopia, Inc.FS102025-07-09
00819567017884ComfytopiaComfytopia, Inc.FS102025-07-09
00819567017891ComfytopiaComfytopia, Inc.KS102025-07-09
00819567017907ComfytopiaComfytopia, Inc.KS102025-07-09
00854194003121ComfytopiaComfytopia, Inc.FS102025-07-09
00854194003138ComfytopiaComfytopia, Inc.KS102025-07-09
00860013109868Lower Limb OrthoticsBoston Brace International, Inc.Knee Orthosis (KO)2025-04-11
00860013109875Lower Limb OrthoticsBoston Brace International, Inc.Knee Ankle Foot Orthosis (KAFO)2025-04-11
00860013109882Lower Limb OrthoticsBoston Brace International, Inc.Hip Knee Ankle Foot Orthosis (HKAFO)2025-04-11
00860013109899Lower Limb OrthoticsBoston Brace International, Inc.Reciprocating Gait Orthosis (RGO)2025-04-11
00840194471787DF2ORTHOPEDIATRICS CORP.03-DF2B-00512024-07-10
00840194471794DF2ORTHOPEDIATRICS CORP.03-DF2B-01512024-07-10
00840194471817DF2ORTHOPEDIATRICS CORP.03-DF2B-00522024-07-10
00840194471824DF2ORTHOPEDIATRICS CORP.03-DF2B-01522024-07-10
00840194471831DF2ORTHOPEDIATRICS CORP.03-DF2B-00532024-07-10
00840194471855DF2ORTHOPEDIATRICS CORP.03-DF2B-01532024-07-10
00840194471862DF2ORTHOPEDIATRICS CORP.03-DF2B-00542024-07-10
00840194471879DF2ORTHOPEDIATRICS CORP.03-DF2B-01542024-07-10
00840194471893DF2ORTHOPEDIATRICS CORP.03-DF2B-00552024-07-10
00840194471909DF2ORTHOPEDIATRICS CORP.03-DF2B-01552024-07-10
00840194471916DF2ORTHOPEDIATRICS CORP.03-DF2B-00562024-07-10
00840194471930DF2ORTHOPEDIATRICS CORP.03-DF2B-01562024-07-10
04719879644753ComfyHealthComfy Health Group Co., Ltd.FP422023-12-06
04719879644760ComfyHealthComfy Health Group Co., Ltd.FP422023-12-06
04719879644777ComfyHealthComfy Health Group Co., Ltd.FP422023-12-06
04719879644784ComfyHealthComfy Health Group Co., Ltd.FP422023-12-06
04719879644791ComfyHealthComfy Health Group Co., Ltd.FP422023-12-06
04719879644807ComfyHealthComfy Health Group Co., Ltd.FP422023-12-06
04719879644814ComfyHealth Comfy Health Group Co., Ltd.FP422023-12-06
04719879644746ComfyHealthComfy Health Group Co., Ltd.FP422023-12-05
04719879641080ComfyHealthComfy Health Group Co., Ltd.KE602023-10-26
04719879641097ComfyHealthComfy Health Group Co., Ltd.KE602023-10-26
04719879641103ComfyHealthComfy Health Group Co., Ltd.KE602023-10-26
04719879641110ComfyHealthComfy Health Group Co., Ltd.KE602023-10-26
04719879641042ComfyHealthComfy Health Group Co., Ltd.KE602023-10-24
04719879641059ComfyHealthComfy Health Group Co., Ltd.KE602023-10-24
04719879641066ComfyHealthComfy Health Group Co., Ltd.KE602023-10-24
04719879641073ComfyHealthComfy Health Group Co., Ltd.KE602023-10-24
00840194462815Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-00012023-06-25
00840194462822Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-01012023-06-25
00840194462839Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-00022023-06-25
00840194462846Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-01022023-06-25
00840194462853Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-00032023-06-25
00840194462860Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-01032023-06-25
00840194462877Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-00042023-06-25
00840194462884Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-01042023-06-25
00840194462891Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-00052023-06-25
00840194462907Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-01052023-06-25
00840194462914Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-00062023-06-25
00840194462921Dynamic Femur Fracture BraceORTHOPEDIATRICS CORP.NS-DF2B-01062023-06-25
00802357130313ProSplintsMEDICAL SPECIALTIES INCORPORATED1130312022-12-07
00802357130320ProSplintsMEDICAL SPECIALTIES INCORPORATED1130322022-12-07
00802357130344ProsplintsMEDICAL SPECIALTIES INCORPORATED1130342022-12-07
04719879643329ComfyHealthComfy Health Group Co., Ltd.LE702022-11-18
04719879643336ComfyHealthComfy Health Group Co., Ltd.LE702022-11-18
04719879643466ComfyHealthComfy Health Group Co., Ltd.FE902022-11-18
04719879643473ComfyHealthComfy Health Group Co., Ltd.FE902022-11-18
04719879643480ComfyHealthComfy Health Group Co., Ltd.FE902022-11-18
04719879644524ComfyHealthComfy Health Group Co., Ltd.FS602022-11-18
04719879644531ComfyHealthComfy Health Group Co., Ltd.FS602022-11-18
04719879644548ComfyHealthComfy Health Group Co., Ltd.FS602022-11-18
04719879644555ComfyHealthComfy Health Group Co., Ltd.FS602022-11-18
04719879640007ComfyHealthComfy Health Group Co., Ltd.KP312022-09-30