FDA.reportPublic FDA data

Johari Digital Healthcare Limited

Primary DI
08908008085147
Brand
Johari Digital Healthcare Limited
Company
SYRMA JOHARI MEDTECH LIMITED
Model
J-STIM2/4
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073386000JOINT STIM, MODEL 1000Pain Management Technologies2008-07-30NYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908008085147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908008085147089080080851478908008085147

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
675938472
Device count
1
Serial number
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
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNYN2026-05-27
06977159460037GYMMAXGymmax Technology (Shenzhen) Co., Ltd.NYN2026-04-24
06976287180336Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180343Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
04719872263029Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
04719872264132Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
06971712720125ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-12-10
00810140062697RENPHOJoicom CorporationNYN2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NYN2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NYN2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NYN2025-09-11
00810113683379DualPulse CompactManamed, Inc.NYN2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NYN2025-09-11
06971712720057NEOCARBONHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-08-31
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NYN2025-08-21
03770018808239actiTENSSUBLIMEDNYN2025-02-07
00092237626870TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626856TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626863TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
06924607702959Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702966Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702973Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702980Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17