FDA.reportPublic FDA data

Steadys-Step

Primary DI
04650075332078
Brand
Steadys-Step
Company
NEUROSOFT, OOO
Model
Steadys-Step
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.
Published
2023-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04650075332078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04650075332078046500753320784650075332078

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
643212926
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04650075337783CloudTMS EdgeMain unit2026-01-23
04650075336922RivusRivus2024-12-20
04650075339992RivusRivus2023-02-02
04650075335895CloudTMS Edge for OCDMain unit2024-01-12
04650075335932CoudTMS Edge for OCDExtra power supply unit2024-01-12
04650075335949CloudTMS Edge for OCDIrbis cooling unit2024-01-12
04650075333792CloudTMS for OCDMain unit2023-12-14
04650075333952CloudTMS for OCDCooling unit2023-12-14
04650075333969CloudTMS for OCDExtra power supply unit2023-12-14
04650075330036Neuro-AudioNeuro-Audio2016-09-22
04650075330081CloudEKGCloudEKG2016-09-21
04650075330296CloudTMSCloudTMS2017-12-21
04650075334003aTympaTymp2023-02-02
04650075331392Neuron-Spectrum-AMNeuron-Spectrum-AM2022-12-19
04650075333211Neuron-SpectrumCloudEEG2021-07-22
04650075330074FocusFocus2016-09-22
04650075330098Neuron-SpectrumNeuron-Spectrum-12016-09-22
04650075330104Neuron-SpectrumNeuron-Spectrum-22016-09-22
04650075330111Neuron-SpectrumNeuron-Spectrum-32016-09-22

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04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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