Steadys-Step

GUDID 04650075332078

System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) data obtained with inertial sensors.

NEUROSOFT, OOO

Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set

• Primary Device ID: 04650075332078
• NIH Device Record Key: 177562ec-8dde-4ac5-9946-9a3c19fd5f96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steadys-Step
• Version Model Number: Steadys-Step
• Company DUNS: 643212926
• Company Name: NEUROSOFT, OOO
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04650075332078 [Primary]

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: 2023-08-22
• Device Publish Date: 2023-08-14

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