Home GUDID 04719879642889 ComfyHealth
Primary DI 04719879642889
Brand ComfyHealth
Company Comfy Health Group Co., Ltd.
Model FP31
Device description BRACOO FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black L/XL
Published 2025-07-10
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 IQI Orthosis, Limb Brace
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IQI Orthosis, Limb Brace Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04719879642889 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719879642889 04719879642889 4719879642889
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 658202517 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 00810178883127 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883134 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883141 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883158 Vive VIVE HEALTH LLC IQI 2026-07-21 00400000326986 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000326993 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327006 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327013 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327020 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327037 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327044 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327051 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327068 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327075 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327082 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327099 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327105 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327112 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327129 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327136 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327143 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327150 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327167 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327174 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327181 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327198 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327204 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327211 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327228 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327235 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20