FDA.reportPublic FDA data

Flow Neuroscience

Primary DI
17314585010010
Brand
Flow Neuroscience
Company
Flow Neuroscience AB
Model
FL-PADS-48
Catalog number
FL-PADS-48
Device description
Kit for US market comprises of: 2x 17314585010003 (two boxes of 24 PADS each)
Published
2026-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
P230024001

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17314585010010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731458501001017314585010010

Regulatory Flags#

DUNS number
350491899
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
17314581000107Flow NeuroscienceFL-100-A-US-PADS-48FL-100-A-US-PADS-482026-07-24
07314581000001Flow NeuroscienceFL-100FL-1002026-06-24
17314585010003Flow NeuroscienceFL-PADS-24FL-PADS-242026-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17314581000107Flow NeuroscienceFlow Neuroscience ABJXK2026-07-24
17314585010003Flow NeuroscienceFlow Neuroscience ABJXK2026-07-02
07314581000001Flow NeuroscienceFlow Neuroscience ABJXK2026-06-24
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