Home GUDID B179BAIO11 baiobit
Primary DI B179BAIO11
Brand baiobit
Company BTS SPA
Model 1
Device description BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional movement analysis.
Published 2020-12-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HCC Device, Biofeedback
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCC Device, Biofeedback Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B179BAIO11 Package HIBCC 1 In Commercial Distribution B179BAIO1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Gait analysis system An assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions.
Regulatory Flags# DUNS number 428484518 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 false 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 04560340091435 Medical HAL Lower Limb Type CYBERDYNE, INC. HCC 2026-04-22 04560340091749 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091756 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091763 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091770 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091787 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091794 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091800 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091817 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 04560340091824 Medical HAL Lumbar Type CYBERDYNE, INC. HCC 2026-04-22 06970670070334 XFT Shenzhen XFT Medical Limited HCC 2026-04-14 00816271020377 Noraxon Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020407 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020414 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020421 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020438 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020445 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020452 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020469 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020476 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020483 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020490 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020506 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020513 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020520 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020735 Core Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020766 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020773 Core Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020889 Ultium / Core Noraxon U.S.A., Inc. HCC 2026-03-30 00816271020896 Ultium Noraxon U.S.A., Inc. HCC 2026-03-30