Computerized Cognitive Assessment Aid, Exempt
Neurology · 21 CFR 882.1470
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.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
42 firms currently registered for this product code
Hipposcreen Neurotech Corp.
Neihu Dist. Taipei, TW
Neurotrax Corp
Naples, FL, US
Shanghai Bestcovered Limited
Shanghai, CN
Linus Health, Inc.
Boston, MA, US
Seven Point One
Seoul, KR
Impact Applications, Inc.
Itasca, IL, US
Posit Science
San Francisco, CA, US
Moca Test Inc.
Greenfield Park Quebec, CA
Spark Neuro, Inc.
New York, NY, US
Videra Health
Orem, UT, US
Hasomed Gmbh
Magdeburg Saxony-Anhalt, DE
Neurocatch Inc.
Surrey British Columbia, CA
Saccade Analytics Inc
Toronto Ontario, CA
Bertec Corp.
COLUMBUS, OH, US
Xrhealth R&d Ltd.
Tel-Aviv Tel Aviv, IL
Sway Medical, Inc.
Tulsa, OK, US
Vista Lifesciences, Inc.
Englewood, CO, US
Gt Diagnostics (uk) Limited
Aberdeen Aberdeen City, GB
Voxneuro, Inc.
Toronto Ontario, CA
Cognivue, Inc.
Victor, NY, US
Sportgait, Inc.
Wilmington, NC, US
Bioventus Llc
Cordova, TN, US
Braincheck, Inc.
Austin, TX, US
Cns Vital Signs
Morrisville, NC, US
H2 Cognitive Designs Ltd
London London, City of, GB
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.