AccessGUDID - DEVICE: Parky (00860009869707)

GUDID

Device Identifier (DI) Information

Brand Name: Parky
Version or Model: V1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI

Primary DI Number: 00860009869707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533148858 *Terms of Use

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 dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32546	Tremor transducer	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYD	Transducer, Tremor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220820	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 666eaa29-0435-49ce-9475-57d01efa4a8d
Public Version Date: April 04, 2023
Public Version Number: 1
DI Record Publish Date: March 27, 2023