What is FDA product code PTY?

This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 882.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Neurology › DiagnosticComputerized Cognitive Assessment Aid, Exempt

HiPAL Pro

Name: HiPAL Pro
Brand: HiPAL Pro

HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated…

Registry build 21.09.26

HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and interpreted by a licensed medical professional through an accompanying web portal.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code PTY
Manufacturer	City	Province	Registered as	Device types
Shanghai Bestcovered Limited	Shanghai	Shanghai	Manufacturer	2
Yiwei Medical Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	1

Record

Regulatory record for HiPAL Pro
Listed by	GT Diagnostics (UK) Limited, United Kingdom
FDA product code	PTY
Device type	Computerized Cognitive Assessment Aid, Exempt
Device class	Class 2
Regulation	21 CFR 882.1470
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2023-07-28

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for HiPAL Pro
Catalogue number	Size	Status
1.0.1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
DCTclock	Linus Health, Inc.	11
Intellispace™ Cognition	Philips Electronics Nederland B.V.	6
NeuroCatch Platform	NeuroCatch Inc.	4
Cognigram	Cogstate Ltd	4
NeuroCatch EEG Cap	NeuroCatch Inc.	4
Core Cognitive Evaluation	Linus Health, Inc.	2
Floodlight MS Cognitive Test	Roche Molecular Systems, Inc.	2
VRCogni	XR Health IL Ltd	2
Cognivue Clarity	Cognivue, Inc.	2
Cognivue Thrive	Cognivue, Inc.	2
Speech Vitals – Cognition	Aural Analytics, Inc.	2
Mspt Web v3.0	Qr8 Health Inc	1

Showing 12 of 48. All products under Computerized Cognitive Assessment Aid, Exempt

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.