AccessGUDID - DEVICE: Steadys-Step (04650075332078)

GUDID

Device Identifier (DI) Information

Brand Name: Steadys-Step
Version or Model: Steadys-Step
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEUROSOFT, OOO

Primary DI Number: 04650075332078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 643212926 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63313	Kinesiology/electromyographic sensor set	A collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 177562ec-8dde-4ac5-9946-9a3c19fd5f96
Public Version Date: August 22, 2023
Public Version Number: 1
DI Record Publish Date: August 14, 2023