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Kinesis Gait

FDA UDI

Class I (US FDA UDI)

by Kinesis

Identity

Trade Name
Kinesis Gait FDA UDI
Generic Name
Gait analysis system FDA UDI
Device Name
Kinesis Gait consists of a device for assessment of gait and movement through quantitative analysis of gait using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device. FDA UDI
Model / Reference
2.0.1 FDA UDI
Description
Kinesis Gait consists of a device for assessment of gait and movement through quantitative analysis of gait using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device. FDA UDI

Identifiers

Primary DI / UDI-DI
05391542950010 FDA UDI
FDA Product Code
PJP FDA UDI
GMDN Term
Gait analysis system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.2400 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Gait analysis system

Kinesis Gait by Kinesis — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gait analysis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kinesis

Sources (1)

  • FDA UDI ba3d10c5-7279-451d-83de-e984374baefb 33 fields · synced May 30, 2026