FDA.reportPublic FDA data

Kinesia 360

Primary DI
00859584006065
Brand
Kinesia 360
Company
Great Lakes Neurotechnologies Inc.
Model
502-0271-1, Tablet Assembly
Device description
Kinesia 360, Tablet Assembly, Samsung Galaxy
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYDTransducer, Tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYDTransducer, TremorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063872000KINESIACleveland Medical Devices, Inc.2007-04-06GYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859584006065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859584006065008595840060658595840060650859584006065

GMDN Terms#

Term, Definition table
TermDefinition
Tremor transducerA device used together with a parent device (e.g., a tremograph) for the measurement of the degree of tremor caused by certain diseases. This can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-619-5918mphillips@glneurotech.com

Regulatory Flags#

DUNS number
965540359
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859584006157KinesiaU700-0027 KinesiaU Kit700-00272024-01-03
00859584006140Kinesia One-C700-00282022-08-24
00859584006102KinesiaU (iOS)700-0026700-00262021-02-17
00859584006096KinesiaU700-0025700-00252019-10-21
00859584006003Kinesia One700-0019, WiFi2016-09-12
00859584006010Kinesia One502-0269, Tablet Assembly, WiFi2016-09-13
00859584006027Kinesia One502-0263, Sensor Assembly2016-09-13
00859584006034Kinesia One700-0019-1, WiFi plus Cellular2016-09-13
00859584006041Kinesia One502-0270, Tablet Assembly, WiFi plus Cellular2016-09-13
00859584006058Kinesia 360700-0020-1, Samsung Galaxy Tablet2016-09-13
00859584006072Kinesia 360 502-0264, Sensor Upper2016-09-13
00859584006089Kinesia 360502-0265, Sensor Lower2016-09-13
00859584006119Kinesia One360-0040, Application Software2016-09-13
00859584006126Kinesia 360360-0041, Application Software2016-09-13
00859584006133Kinesia360-2005, Web Portal Software Application2016-09-13
00859584006164Kinesia360-2011, Kinesia Web App/Portal 22016-11-10
00859584006171Kinesia 360360-0048, Support Application Software2017-02-23
00859584006188Kinesia StimPoint502-0277 Kinesia StimPoint Sensor502-02772018-06-27
00859584006195Kinesia StimPoint360-0050 Kinesia StimPoint Software360-00502018-06-27
00859584006201Kinesia StimPoint 700-0024 Kinesia StimPoint System700-00242018-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859584006157KinesiaUGreat Lakes Neurotechnologies Inc.GYD2024-01-03
00860009869707ParkyH2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETIGYD2023-03-27
00859584006140Kinesia One-CGreat Lakes Neurotechnologies Inc.GYD2022-08-24
00859584006102KinesiaU (iOS)Great Lakes Neurotechnologies Inc.GYD2021-02-17
00859584006096KinesiaUGreat Lakes Neurotechnologies Inc.GYD2019-10-21
00859584006270Kinesia 360Great Lakes Neurotechnologies Inc.GYD2019-01-28
00859584006188Kinesia StimPointGreat Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006195Kinesia StimPointGreat Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006201Kinesia StimPoint Great Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006218Kinesia StimPoint Great Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006225Kinesia StimPointGreat Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006232KinesiaGreat Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006249Kinesia Great Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006256Kinesia 360Great Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006263Kinesia 360Great Lakes Neurotechnologies Inc.GYD2018-06-27
00859584006171Kinesia 360Great Lakes Neurotechnologies Inc.GYD2017-02-23
00859584006164KinesiaGreat Lakes Neurotechnologies Inc.GYD2016-11-10
00859584006010Kinesia OneGreat Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006027Kinesia OneGreat Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006034Kinesia OneGreat Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006041Kinesia OneGreat Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006058Kinesia 360Great Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006072Kinesia 360 Great Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006089Kinesia 360Great Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006119Kinesia OneGreat Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006126Kinesia 360Great Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006133KinesiaGreat Lakes Neurotechnologies Inc.GYD2016-09-13
00859584006003Kinesia OneGreat Lakes Neurotechnologies Inc.GYD2016-09-12