FDA-Device2019-12-18Class II
Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.
Neuronetrix Solutions, LLC dba Cognision
Hazard
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Sold states
US Nationwide distribution.
Affected count
3,108 units
Manufactured in
1044 E Chestnut St, N/A, Louisville, KY, United States
Products
Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2020Don't want to check this manually?
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