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Data / Medical devices / Computerized Cognitive Assessment Aid, Exempt

Computerized Cognitive Assessment Aid, Exempt (PTY): 40 FDA-registered makers in 11 countries

40 establishments in 11 countries are registered with the FDA to make Computerized Cognitive Assessment Aid, Exempt (product code PTY, Class 2, 21 CFR 882.1470). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
PTY
Device class
2
Regulation
882.1470
Medical specialty
Neurology

Makers by country

CountryMakers
United States22
Canada4
United Kingdom4
Germany2
China2
France1
Taiwan1
Ireland1
Singapore1
South Korea1
Israel1

Makers of Computerized Cognitive Assessment Aid, Exempt

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ad ScientiamParis Ile-de-France, FranceManufacturer0000api.fda.gov
Bertec Corp.Columbus, OH, United StatesManufacturer0000api.fda.gov
Braincheck, Inc.Austin, TX, United StatesManufacturer0000api.fda.gov
Bioventus LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Cambridge Brain Sciences Inc. (o/A Creyos)Toronto Ontario, CanadaManufacturer0000api.fda.gov
Cambridge Cognition Ltd.Bottisham Cambridgeshire, United KingdomManufacturer0000api.fda.gov
CNS Vital SignsMorrisville, NC, United StatesManufacturer0000api.fda.gov
CognifitSan Francisco, CA, United StatesManufacturer0000api.fda.gov
Cognivue, Inc.Victor, NY, United StatesManufacturer0000api.fda.gov
Cogstate LtdNew Haven, CT, United StatesManufacturer0000api.fda.gov
GT Diagnostics (UK) LimitedAberdeen Aberdeen City, United KingdomManufacturer0000api.fda.gov
H2 Cognitive Designs LtdLondon London, City of, United KingdomManufacturer0000api.fda.gov
Hasomed GMBHMagdeburg Saxony-Anhalt, GermanyManufacturer0000api.fda.gov
Hhitt, Inc.San Francisco, CA, United StatesSpecification developer0000api.fda.gov
Hipposcreen Neurotech Corp.Neihu Dist. Taipei, TaiwanManufacturer0000api.fda.gov
Head Diagnostics LtdDublin Dublin(County), IrelandManufacturer0000api.fda.gov
Impact Applications, Inc.Itasca, IL, United StatesManufacturer0000api.fda.gov
Kneu Health LimitedLondon London, City of, United KingdomSpecification developer0000api.fda.gov
Linus Health, Inc.Boston, MA, United StatesManufacturer0000api.fda.gov
Mindtrace Technologies, Inc.Pittsburgh, PA, United StatesManufacturer0000api.fda.gov
Moca Test Inc.Greenfield Park Quebec, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Neotiv GMBHMagdeburg Saxony-Anhalt, GermanyManufacturer0000api.fda.gov
Neurotone Ai, IncGainesville, FL, United StatesManufacturer0000api.fda.gov
Neurotrack TechnologiesRedwood City, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Neurotrax CorpNaples, FL, United StatesManufacturer0000api.fda.gov
Neurowyzr Pte Ltd.Singapore Central Singapore, SingaporeManufacturer0000api.fda.gov
NeuroCatch Inc.Surrey British Columbia, CanadaManufacturer0000api.fda.gov
Posit ScienceSan Francisco, CA, United StatesManufacturer0000api.fda.gov
Saccade Analytics IncToronto Ontario, CanadaManufacturer0000api.fda.gov
Seven Point OneSeoul, South KoreaManufacturer0000api.fda.gov
Shanghai Bestcovered LimitedShanghai, ChinaManufacturer0000api.fda.gov
Spark Neuro, Inc.New York, NY, United StatesManufacturer0000api.fda.gov
Sportgait, Inc.Wilmington, NC, United StatesManufacturer0000api.fda.gov
Sway Medical, Inc.Tulsa, OK, United StatesManufacturer0000api.fda.gov
Videra HealthOrem, UT, United StatesManufacturer0000api.fda.gov
Virgo Usa R&D CorpGreat Neck, NY, United StatesManufacturer0000api.fda.gov
Vista Lifesciences, Inc.Englewood, CO, United StatesManufacturer0000api.fda.gov
Vistim Labs Inc.Claymont, DE, United StatesSpecification developer0000api.fda.gov
Xrhealth R&D Ltd.Tel-Aviv Tel Aviv, IsraelManufacturer0000api.fda.gov
Yiwei Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.