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

Brain Gauge MD

Name: Brain Gauge MD
Brand: Brain Gauge MD

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the…

Registry build 21.09.26

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient’s hand.

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 Brain Gauge MD
Listed by	Cortical Metrics, LLC
FDA product code	PTY
Device type	Computerized Cognitive Assessment Aid, Exempt
Device class	Class 2
Regulation	21 CFR 882.1470
Premarket notification	Exempt
Record published	2018-11-27
Record revised	2019-04-23 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date, serial number
Storage	Storage environment temperature 5 to 24 °C
Sizes	Depth 73 mm; width 113 mm; height 40 mm

Catalogue Numbers

Catalogue numbers for Brain Gauge MD
Catalogue number	Size	Status
1.0	Depth 73 mm	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.