Question 1

What types of medical devices does Great Lakes NeuroTechnologies Inc manufacture?

Accepted Answer

Great Lakes NeuroTechnologies Inc specializes in tremor transducers, which are devices used to measure and analyze movement disorders. These products, such as the Kinesia 360, Kinesia, Kinesia One, and Kinesia StimPoint, focus on assessing tremor severity and tracking the effectiveness of treatments for neurological conditions.

Question 2

Where is Great Lakes NeuroTechnologies Inc based?

Accepted Answer

The company is headquartered in the United States. This location influences its regulatory compliance, particularly in relation to FDA requirements and UDI listings.

Question 3

Which regulatory registries list Great Lakes NeuroTechnologies Inc’s devices?

Accepted Answer

The company’s devices are listed in the EU’s EUDAMED registry and the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of medical devices across different markets.

Question 4

How are Great Lakes NeuroTechnologies Inc’s tremor transducers classified?

Accepted Answer

The company’s tremor transducers fall into two regulatory classes: Class I and Class II. Classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety, with Class II typically involving higher regulatory scrutiny due to moderate risk.

Device	Model / Reference	Registries	Class	Status
Kinesia 360	360-0048, Support Application Software	FDA UDI	Class II	Active
Kinesia	502-0268 Kinesia Finger Sleeves	FDA UDI	Class II	Active
Kinesia One	502-0269, Tablet Assembly, WiFi	FDA UDI	Class II	Active
Kinesia StimPoint	360-0050 Kinesia StimPoint Software	FDA UDI	Class II	Active
Kinesia StimPoint	700-0024 Kinesia StimPoint System	FDA UDI	Class II	Active
Kinesia 360	502-0265, Sensor Lower	FDA UDI	Class II	Active
Kinesia	360-2005, Web Portal Software Application	FDA UDI	Class II	Active
Kinesia 360	700-0020-3 K360 Flex	FDA UDI	Class II	Active
Kinesia One	502-0263, Sensor Assembly	FDA UDI	Class II	Active
Kinesia StimPoint	502-0277 Kinesia StimPoint Sensor	FDA UDI	Class II	Active
Kinesia 360	360-0041, Application Software	FDA UDI	Class II	Active
Kinesia StimPoint	502-0276 Kinesia StimPoint Tablet Assembly	FDA UDI	Class II	Active
KinesiaU	700-0027 KinesiaU Kit	FDA UDI	Class II	Active
Kinesia One	360-0040, Application Software	FDA UDI	Class II	Active
Kinesia	360-2011, Kinesia Web App/Portal 2	FDA UDI	Class II	Active
Kinesia 360	502-0264, Sensor Upper	FDA UDI	Class II	Active
Kinesia One-C	700-0028	FDA UDI	Class II	Active
Kinesia One	502-0270, Tablet Assembly, WiFi plus Cellular	FDA UDI	Class II	Active
Kinesia 360	502-0271-1, Tablet Assembly	FDA UDI	Class II	Active
Kinesia 360	502-0271-1 K360 Tablet	FDA UDI	Class II	Active
Kinesia	059-0013 Kinesia Charge Pad	FDA UDI	Class II	Active
Kinesia StimPoint	392-0067 Kinesia StimPoint User Guide	FDA UDI	Class II	Active
Kinesia ONE	Kinesia ONE 700-0019	EUDAMEDFDA UDI	Class I	Active
Kinesia ONE	Kinesia U - 700-0026	EUDAMEDFDA UDI	Class I	Active
Kinesia ONE	Kinesia U 700-0025	EUDAMEDFDA UDI	Class I	Active
Kinesia ONE	Kinesia 360 700-0019-2	EUDAMEDFDA UDI	Class I	Active
Kinesia ONE	Kinesia One 700-0019-1	EUDAMEDFDA UDI	Class I	Active
Kinesia ONE	Kinesia 360 - 700-0020-2	EUDAMEDFDA UDI	Class I	Active

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