FDA.reportPublic FDA data

Parky

Primary DI
00860009869707
Brand
Parky
Company
H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
Model
V1
Device description
Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesiaepisodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcareprofessional through email.
Published
2023-03-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GYDTransducer, Tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYDTransducer, TremorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220820000Parky AppH2o Bilisim Yazilim2022-11-17GYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009869707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009869707008600098697078600098697070860009869707

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

Regulatory Flags#

DUNS number
533148858
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859584006157KinesiaUGreat Lakes Neurotechnologies Inc.GYD2024-01-03
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
00859584006065Kinesia 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