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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFlow FL-100
Generic NameCranial electrotherapy stimulator to treat depression
Regulation Number882.5800
ApplicantFlow Neuroscience AB
470 Ramona St.
Palo Alto, CA 94301
PMA NumberP230024
Supplement NumberS001
Date Received04/15/2026
Decision Date07/14/2026
Product Code JXK 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for minor device design changes, editorial and maintenance updates to existing firmware, server and application documentation, clarification updates to accessory pad specifications, and a minor mechanical design change.
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