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 00636257220733 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220740 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220757 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220764 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220771 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220788 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220795 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220801 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220887 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220894 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220900 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220917 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220924 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220931 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220948 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220955 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220962 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220979 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220986 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257220993 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257221006 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257221068 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257221075 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00636257221082 MEDI MEDI MANUFACTURING, INC. IQI 2026-10-12 00840536824288 PediHip ORTHOPEDIATRICS CORP. IQI 2026-10-07 00840536824295 PediHip ORTHOPEDIATRICS CORP. IQI 2026-10-07 00840536824301 PediHip ORTHOPEDIATRICS CORP. IQI 2026-10-07 00840536824318 PediHip ORTHOPEDIATRICS CORP. IQI 2026-10-07 00840536824325 PediHip ORTHOPEDIATRICS CORP. IQI 2026-10-07 00840536824332 PediHip ORTHOPEDIATRICS CORP. IQI 2026-10-07