Neurotrack Cognitive Assessment Battery

Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment,…

Registry build 21.09.26

Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes. The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.

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 Neurotrack Cognitive Assessment Battery
Listed by Neurotrack Technologies, United States
FDA product code PTY
Device type Computerized Cognitive Assessment Aid, Exempt
Device class Class 2
Regulation 21 CFR 882.1470
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-12-15

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Neurotrack Cognitive Assessment Battery
Catalogue number Size Status
1.1.0 In distribution

Same Product Code

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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer