baiobit

GUDID B179BAIO11

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.

BTS SPA

Gait analysis system

• Primary Device ID: B179BAIO11
• NIH Device Record Key: dc85782e-1009-4206-a29c-3d271d14d03b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: baiobit
• Version Model Number: 1
• Company DUNS: 428484518
• Company Name: BTS SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B179BAIO1 [Primary]
HIBCC	B179BAIO11 [Package]; Contains: B179BAIO1; Package: customized boxes [1 Units]; In Commercial Distribution

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-22
• Device Publish Date: 2020-12-14

Devices Manufactured by BTS SPA

• B179SEVBUN050 - SMART: 2025-01-06 SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for the recording and analysis of huma
• B179SEVBUN090 - SMART: 2025-01-06 SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for the recording and analysis of huma
• B179SEVBUN260 - SMART: 2025-01-06 SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for the recording and analysis of huma
• B179SDXEVO1 - SMART: 2023-09-14 SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of reha
• B179BAIO11 - baiobit: 2020-12-22BAIOBIT 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.
• B179BAIO11 - baiobit: 2020-12-22 BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tr
• B179SDX - SMART: 2018-07-06 SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of reha
• B179THN1 - TEETHAN: 2018-07-06 Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter T
• B179FE31 - FREEEMG: 2018-03-29 BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequen