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KinesiaU

FDA UDI

Class II (US FDA UDI)

by Great Lakes NeuroTechnologies Inc

Identity

Trade Name
KinesiaU FDA UDI
Generic Name
Tremor transducer FDA UDI
Model / Reference
700-0027 KinesiaU Kit FDA UDI

Identifiers

Catalog Number
700-0027 FDA UDI
Primary DI / UDI-DI
00859584006157 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tremor transducer

KinesiaU 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 352df1fd-792d-4f0c-a8cc-1286c6da64f9 34 fields · synced May 30, 2026