Parky

GUDID 00860009869707

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.

H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI

Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer

• Primary Device ID: 00860009869707
• NIH Device Record Key: 666eaa29-0435-49ce-9475-57d01efa4a8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parky
• Version Model Number: V1
• Company DUNS: 533148858
• Company Name: H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009869707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220820

FDA Product Code

• GYD: Transducer, Tremor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-03-27