Flow FL-100
by Flow Neuroscience AB EUDAMEDPMAGUDID
Active
PMA P230024Ref 1Model FL-100
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07314581000001 | Date24 Jun 2026 | StatusListed |
| United States | FDA PMAAPPR PMA | NumberP230024 | Date8 Dec 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | NumberB-07314581000001 | Date12 Dec 2024 | StatusActive |
| European Union | CE/MDD EUDAMED | NumberB-07314581000001 | Date12 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Flow FL-100 EUDAMEDPMAFlow EUDAMEDFlow Neuroscience GUDID
- Generic Name
- Cranial electrotherapy stimulator to treat depression PMATranscranial electrical stimulation system, continuous-current, home-use GUDID
- Model / Ref / Catalog
- FL-100, 1
- Primary DI / UDI-DI
- 07314581000001
- Basic UDI-DI
- B-07314581000001, 731458FL-100RN
- Direct Marketing DI
- 07314581000001
- PMA Number
- FDA Product Code
- JXK
- EMDN Code
- N0199 Encephalic and peripheral nervous system devices - other
- GMDN Term
- Transcranial electrical stimulation system, continuous-current, home-use
- Device Class
- Class IIa EUDAMEDClass III PMAGUDID
- Regulation
- 21 CFR Part 882.5800
- Market of Registration
- Sweden
- Advisory Committee
- Neurology
- FDA Decision
- APPR Approved
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | PMA | GUDID |
|---|---|---|---|
| Generic Name | n/a | Cranial electrotherapy stimulator to treat depression | Transcranial electrical stimulation system, continuous-current, home-use |
| Device Class | Class IIa | Class III | Class III |
Overview
AI-generated summary, 18 Sep 2026
The Flow Fl-100 is a cranial electrotherapy stimulator, a device used to treat depression. It 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. The device is classified as a class 3 device and is regulated under the regulation number 882.5800. The Flow Fl-100 is manufactured by Flow Neuroscience AB and has been authorized with FDA_PMA, MDD, and MDR authorizations.
The Flow Fl-100 is supplied as a cranial electrotherapy stimulator to treat depression, with a product code of JXK and registration numbers 3019551144, 3015088397, and 3040334342. The device is used in the field of neurology and is designed for use in patients with moderate to severe major depressive disorder. The Flow Fl-100 has a specific medical specialty description of neurology and is classified as a cranial electrotherapy stimulator to treat depression.
Other devices from Flow Neuroscience AB
Questions
AI-generated answers, 18 Sep 2026
What is the Flow Fl-100 used for?
The Flow Fl-100 is used 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.
What authorizations does the Flow Fl-100 have?
The Flow Fl-100 has been authorized with FDA_PMA, MDD, and MDR authorizations.
What is the product code of the Flow Fl-100?
The product code of the Flow Fl-100 is JXK.
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Expiration Date: No