Home GUDID 00860010894859 Bio Leg™
Primary DI 00860010894859
Brand Bio Leg™
Company BIONICM INC.
Model BLP001T
Device description Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, instruction manual and other printed materials, for Trial
Published 2025-08-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name ISW Assembly, Knee/Shank/Ankle/Foot, External
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ISW Assembly, Knee/Shank/Ankle/Foot, External Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860010894859 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860010894859 00860010894859 860010894859 0860010894859
GMDN Terms# Term, Definition table Term Definition Mechatronic external knee prosthesis A battery-powered electromechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing knee flexion speed and temperature and instantly adjusting motion resistance within a single step. Known as a microprocessor-controlled knee (MPK), it may have various designs and functional features for support during a variety of activities.
Regulatory Flags# DUNS number 717916018 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850004761106 Walkasins RxFunction, Inc. ISW 2026-06-24 00850004761113 Walkasins RxFunction, Inc. ISW 2026-06-24 00850004761120 Walkasins RxFunction, Inc. ISW 2026-06-24 00850004761137 Walkasins RxFunction, Inc. ISW 2026-06-24 00850004761144 Walkasins RxFunction, Inc. ISW 2026-06-24 00850004761151 Walkasins RxFunction, Inc. ISW 2026-06-24 00850004761168 Walkasins RxFunction, Inc. ISW 2026-06-24 00850004761175 Walkasins RxFunction, Inc. ISW 2026-06-24 00860010894842 Bio Leg™ BIONICM INC. ISW 2025-08-21 00860010894804 Bio Leg™ BIONICM INC. ISW 2024-05-24 00860010894811 Bio Leg™ BIONICM INC. ISW 2024-05-24 04032767811571 BiOM T2 OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767811588 BiOM T2 OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767832842 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767832866 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838882 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838899 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838905 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838912 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838929 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838936 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838943 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838950 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838967 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838974 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838981 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767838998 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767839001 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767839018 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11 04032767839025 Empower OTTO BOCK HEALTHCARE ISW 2018-04-11