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Kinesia 360

FDA UDI

Class II (US FDA UDI)

by Great Lakes NeuroTechnologies Inc

Identity

Trade Name
Kinesia 360 FDA UDI
Generic Name
Tremor transducer FDA UDI
Device Name
Kinesia 360, Application Software FDA UDI
Model / Reference
360-0041, Application Software FDA UDI
Description
Kinesia 360, Application Software FDA UDI

Identifiers

Primary DI / UDI-DI
00859584006126 FDA UDI
510(k) Number
K063872 FDA UDI
FDA Product Code
GYD FDA UDI
GMDN Term
Tremor transducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1950 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tremor transducer

Kinesia 360 by Great Lakes NeuroTechnologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tremor transducer.

Cleared under the same submission

K063872 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Great Lakes NeuroTechnologies Inc

Sources (1)

  • FDA UDI 79920f36-116e-429e-b2b7-f4a583f2ff25 35 fields · synced Jun 8, 2026