FDA.reportPublic FDA data

Flow Neuroscience

Primary DI
07314581000001
Brand
Flow Neuroscience
Company
Flow Neuroscience AB
Model
FL-100
Catalog number
FL-100
Device description
The 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 and older who are not considered treatment refractory to medication. For prescription use only (Rx only).
Published
2026-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JXKCranial Electrotherapy Stimulator To Treat Depression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXKCranial Electrotherapy Stimulator To Treat DepressionNeurology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230024000
P230024001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230024000Flow FL-100Flow Neuroscience AB2025-12-08JXK
P230024001Flow FL-100Flow Neuroscience AB2025-12-08JXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07314581000001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07314581000001073145810000017314581000001

GMDN Terms#

Term, Definition table
TermDefinition
Transcranial electrical stimulation system, continuous-current, home-useA noninvasive, electrically powered device/device assembly intended for use by a layperson outside a clinical setting to apply weak continuous (not pulsed) electrical current (typically up to 2 mA) across the skin to the wearer's brain to increase neuroplasticity, and improve concentration and working memory. The technique is commonly referred to as transcranial direct current stimulation (tDCS). It is available in a variety of forms (e.g., wearable headset) and includes controls and multiple electrodes; additional accessories (e.g., sponges intended to be soaked in salt water to conduct the current) may include additional accessories.

Regulatory Flags#

DUNS number
350491899
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17314585010003Flow NeuroscienceFL-PADS-24FL-PADS-242026-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17314585010003Flow NeuroscienceFlow Neuroscience ABJXK2026-07-02
00857869005277Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
00857869005284Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
08908008085406Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDJXK2021-03-12
B788KS02001NexalinNEXALIN TECHNOLOGYJXK2019-10-07
B788KS02000NexalinNEXALIN TECHNOLOGYJXK2019-10-01
00860001493306CervellaINNOVATIVE NEUROLOGICAL DEVICES LLCJXK2019-04-30
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
M750AR635A0CES-UltraNEURO-FITNESS LLCJXK2017-06-30
M750AR635ACES-UltraNEURO-FITNESS LLCJXK2017-02-12
00857869005239TruDenta Earclip Electrode PadElectromedical Products International, Inc.JXK2015-06-30
00857869005161Alpha-Stim Earclip Electrode (M)Electromedical Products International, Inc.JXK2014-08-29
00857869005178Alpha-Stim Earclip Electrode (AID)Electromedical Products International, Inc.JXK2014-08-29
00857869005031Alpha-Stim Earclip Electrode PadElectromedical Products International, Inc.JXK2014-08-25
00857869005079Alpha Conducting SolutionElectromedical Products International, Inc.JXK2014-08-25
00857869005086Alpha Conducting Solution Electromedical Products International, Inc.JXK2014-08-25
00857869005093Alpha-Stim Earclip Electrode (CE3)Electromedical Products International, Inc.JXK2014-08-25
00857869005130Alpha-Stim Earclip Electrode (AID)Electromedical Products International, Inc.JXK2014-08-25