Data / Medical devices / United States / Great Lakes Neurotechnologies Inc.
Great Lakes Neurotechnologies Inc.: FDA-registered device maker in Cleveland, OH, United States, 1 510(k) clearance
Great Lakes Neurotechnologies Inc. is registered with the FDA (registration 3009134706) in Cleveland, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 6, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009134706
- Address
- 6100 Rockside Woods Blvd. Suite 415, Cleveland, OH, United States, 44131
- Owner or operator
- Great Lakes NeuroTechnologies Inc. (10035940)
- Roles
- Manufacturer
- First device listed
- April 5, 2011
- Registered through
- 2026
- Brand names listed
- Kinesia, Kinesia 360, Kinesia HomeView, Kinesia ONE, Kinesia ONE-C, Kinesia ProView, Kinesia StimPoint, KinesiaU
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transducer, Tremor | GYD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2007 | K063872 | KINESIA | GYD | Substantially Equivalent | Cleveland Medical Devices, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 6, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.