Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009134706

FEI Number

3009134706

Entity Name

GREAT LAKES NEUROTECHNOLOGIES INC.

City/State/Country

Cleveland, OH, US

Establishment Address

6100 Rockside Woods Blvd., Suite 415, Cleveland, OH 44131, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Great Lakes NeuroTechnologies Inc. (Owner Number: 10035940)

Owner / Operator Contact Address

6100 Rockside Woods Blvd., Suite 415, Cleveland, OH 44131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063872

PMA Number

N/A

All Registered Proprietary Names

Kinesia ONE KinesiaU Kinesia 360 Kinesia ProView Kinesia HomeView Kinesia StimPoint Kinesia Kinesia ONE-C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GYD	Transducer, Tremor	Neurology	Class 2	882.1950	2011-04-05

Official Correspondent

Dustin Heldman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Great Lakes NeuroTechnologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009134706. Last updated year: 2026. Please use registration number 3009134706 when referencing this establishment in official correspondence.