FDA.reportPublic FDA data

Johari Digital Healthcare Ltd.

Primary DI
08908008085406
Brand
Johari Digital Healthcare Ltd.
Company
SYRMA JOHARI MEDTECH LIMITED
Model
MINDGEAR
Device description
Mindgear is cranial electrotherapy device and it is indicated for use CES for the treatment of insomnia and anxiety. Key Features: 510(K) cleared device, Portable and user-friendly device, Used for the treatment of insomnia and anxiety.
Published
2021-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K090052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090052000CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/CJohari Digital Healthcare , Ltd.2009-05-29QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908008085406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908008085406089080080854068908008085406

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
982-805-4228sjohari@joharidigital.com

Regulatory Flags#

DUNS number
675938472
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908008085307HILL Laboratories CompanyHF542019-01-11
08908008085000Johari Digital Healthcare LimitedWS4U-Combo Device2016-09-19
08908008085017Johari Digital Healthcare LimitedWS2U-Combo Device2016-09-19
08908008085024Johari Digital Healthcare LimitedWSU2016-09-19
08908008085031Johari Digital Healthcare LimitedJUS22016-09-19
08908008085499Syrma Johari MedTech LimitedMyolift QT+2025-07-08
08908008085055Johari Digital Healthcare LimitedX Trainer2016-09-19
08908008085130Johari Digital Healthcare LimitedNMS4982016-09-19
08908008085192Mettler Electronics Corp.SYSSTIM 208/208A2016-09-19
08908008085253Johari Digital Healthcare LimitedNeubie2017-09-11
08908008085260Johari Digital Healthcare LimitedNeuro-M Trainer Model A2017-09-11
08908008085475Johari Digital Healthcare Ltd.MyoBody XT2025-02-04
08908008085468Johari Digital Healthcare Ltd.Zeta Cranial Navigation System2024-01-25
08908008085451Johari Digital Healthcare Ltd.truFlex2024-01-24
08908008085444Johari Digital Healthcare Ltd.MYOLIFT 600+2023-12-04
08908008085437Johari Digital Healthcare Ltd.Myolift TW2023-03-17
08908008085413Johari Digital Healthcare Ltd.Sonicaor Plus 9212021-06-04
08908008085420Johari Digital Healthcare Ltd.Sonicaor Plus 9412021-06-04
08908008085376Johari Digital Healthcare Ltd.Myolift 6002020-10-30
08908008085383Johari Digital Healthcare Ltd.STIM TENS2020-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857869005277Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
00857869005284Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
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