PMA P230024
- Device
- Flow FL-100
- Applicant
- Flow Neuroscience AB
- PMA number
- P230024
- Product code
- JXK
- Decision date
- 2025-12-08
- Classification
- Neurology
- Generic name
- Cranial electrotherapy stimulator to treat depression
- Approval order statement
- FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.
Current openFDA PMA Record#
- Device
- Flow FL-100
- Applicant
- Flow Neuroscience AB
- PMA number
- P230024
- Product code
- JXK
- Generic name
- Cranial electrotherapy stimulator to treat depression
- Decision date
- 2025-12-08
- Decision code
- APPR
- Date received
- 2023-08-07
- Approval order statement
- FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.