PMA P230024S001

Device: Flow FL-100
Applicant: Flow Neuroscience AB
PMA number: P230024
Supplement: S001
Product code: JXK
Decision date: 2026-07-14
Classification: Neurology
Generic name: Cranial electrotherapy stimulator to treat depression
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.

Current openFDA PMA Record#

Device: Flow FL-100
Applicant: Flow Neuroscience AB
PMA number: P230024
Supplement: S001
Product code: JXK
Generic name: Cranial electrotherapy stimulator to treat depression
Decision date: 2026-07-14
Decision code: APPR
Date received: 2026-04-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.