FDA.reportPublic FDA data

Johari Digital Healthcare Ltd.

Primary DI
08908008085383
Brand
Johari Digital Healthcare Ltd.
Company
SYRMA JOHARI MEDTECH LIMITED
Model
STIM TENS
Device description
STIM TENS is cranial electrotherapy device and it provides powerful, predictable, proven stress relieving experience, Treatments for Insomnia. Key Features: 510(K) cleared device, Portable and user-friendly device, Used for Treatments for Anxiety and Insomnia.
Published
2020-10-30
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
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or AnxietyNeurology2

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
08908008085383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908008085383089080080853838908008085383

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
08908008085406Johari Digital Healthcare Ltd.MINDGEAR2021-03-12
08908008085376Johari Digital Healthcare Ltd.Myolift 6002020-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M750AR635A2Calm UltraNEURO-FITNESS LLCQJQ2026-05-21
00860010064634GenesisNeurofield, Inc.QJQ2026-05-07
05070002841210Modius CalmNEUROVALENS LIMITEDQJQ2025-04-04
05070002841203Modius SleepNEUROVALENS LIMITEDQJQ2025-01-23
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
M750AR635A0CES-UltraNEURO-FITNESS LLCQJQ2017-06-30
M750AR635A1CES-UltraNEURO-FITNESS LLCQJQ2017-02-12
08908008085086Solace Lifesciences, IncSYRMA JOHARI MEDTECH LIMITEDQJQ2016-09-19
089080080852087E WellnessSYRMA JOHARI MEDTECH LIMITEDQJQ2016-09-19
00857869005253Alpha-Stim MElectromedical Products International, Inc.QJQ2015-11-30
00857869005260Alpha-Stim AIDElectromedical Products International, Inc.QJQ2015-11-30
00857869005000Alpha-Stim MElectromedical Products International, Inc.QJQ2014-08-25
00857869005017Alpha-Stim AIDElectromedical Products International, Inc.QJQ2014-08-25