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Steadys-Step

FDA UDI

Class II (US FDA UDI)

by Neurosoft, Ooo

Identity

Trade Name
Steadys-Step FDA UDI
Generic Name
Kinesiology/electromyographic sensor set FDA UDI
Device Name
System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) data obtained with inertial sensors. FDA UDI
Model / Reference
Steadys-Step FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
04650075332078 FDA UDI
FDA Product Code
HCC FDA UDI
GMDN Term
Kinesiology/electromyographic sensor set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Kinesiology/electromyographic sensor set

Steadys-Step by Neurosoft, Ooo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kinesiology/electromyographic sensor set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurosoft, Ooo

Sources (1)

  • FDA UDI 177562ec-8dde-4ac5-9946-9a3c19fd5f96 33 fields · synced May 30, 2026