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Parky

FDA UDI

Class II (US FDA UDI)

by H2o Bilisim Yazilim Elektronik Saglik Hizmetleri Sanayi Ve Ticaret Limited Sirketi

Identity

Trade Name
Parky FDA UDI
Generic Name
Tremor transducer FDA UDI
Device Name
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. FDA UDI
Model / Reference
V1 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860009869707 FDA UDI
510(k) Number
K220820 FDA UDI
FDA Product Code
GYD FDA UDI
GMDN Term
Tremor transducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tremor transducer

Parky by H2o Bilisim Yazilim Elektronik Saglik Hizmetleri Sanayi Ve Ticaret Limited Sirketi — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Tremor transducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H2o Bilisim Yazilim Elektronik Saglik Hizmetleri Sanayi Ve Ticaret Limited Sirketi

Sources (1)

  • FDA UDI 666eaa29-0435-49ce-9475-57d01efa4a8d 34 fields · synced May 30, 2026