FDA.reportPublic FDA data

Syrma Johari MedTech Limited

Primary DI
08908008085567
Brand
Syrma Johari MedTech Limited
Company
SYRMA JOHARI MEDTECH LIMITED
Model
TORC PLUS TR-841
Device description
"TR-841 is to provide the clinicians an electrotherapy unit that can deliver precise treatment for varied pain problems and rehabilitation needs and the most comfortable electrical stimulation to patients. It allows clinicians to select and provide the lnterferential or Russian stimulation through 4 outputs. TR-841 combines microcomputer controlled circuitry to provide most effective treatment level to reduce chronic and acute pain, deep diffused pain, edema, swelling and soreness following acute injury and to strengthen muscles. The instrument is constructed of Aluminum and it is attractive, strong, and sturdy and is user friendly. It has a pleasing design and operating structure is constructed very clear, with clear grouping of all channels and their controls."
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IROVibrator, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IROVibrator, TherapeuticPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993600000MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841Nisha Communication Industries2001-02-05LIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908008085567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908008085567089080080855678908008085567

GMDN Terms#

Term, Definition table
TermDefinition
Vibratory biothesiometerAn electronic instrument intended to produce vibrations that are applied to a part of the body (often the great toe) in a range of intensities to noninvasively measure vibratory sensation threshold. Sometimes referred to as a vibrameter, It is typically used for neuropathological diagnoses and evaluation of the neurological health effects of diabetes mellitus, exposure to neurotoxic compounds (e.g., solvents or heavy metals), poor ergonomic working conditions, chemotherapy or trauma.

Regulatory Flags#

DUNS number
675938472
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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
00810140063083RenphoJoicom CorporationIRO2026-06-23
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRO2025-07-15
07898939912272AvaBoots 5.0AVANUTRI EQUIPAMENTOS DE SAUDE LTDAIRO2025-06-25
00810140061423RENPHOJoicom CorporationIRO2024-11-19
00810140061430RENPHOJoicom CorporationIRO2024-11-19
00810140061515RENPHOJoicom CorporationIRO2024-11-19
10810140061420RENPHOJoicom CorporationIRO2024-11-19
10810140061437RENPHOJoicom CorporationIRO2024-11-19
10810140061512RENPHOJoicom CorporationIRO2024-11-19
00840295405568TherabodyTherabody, Inc.IRO2024-11-08
00840295405575TherabodyTherabody, Inc.IRO2024-11-08
00840295405582TherabodyTherabody, Inc.IRO2024-11-08
07290103039653VSA 2 Hand HeldMEDOC LTD.IRO2023-06-20
07290103039660VSA 2 Handheld deviceMEDOC LTD.IRO2023-06-20
07290103039677VSA 2 Hand-Leg supportMEDOC LTD.IRO2023-06-20
00810036056687TheraFaceTherabody, Inc.IRO2022-01-18
00810036056724TheraFaceTherabody, Inc.IRO2022-01-18
00813859002886PretikaPRETIKA CORPORATIONIRO2020-04-30
00813859002619PretikaPRETIKA CORPORATIONIRO2019-07-01
B108714GUNALXC0BTL Cellutone handpieceBTL INDUSTRIES LIMITEDIRO2017-01-12
B108714GUNALXCENUS0BTL Cellutone handpieceBTL INDUSTRIES LIMITEDIRO2017-01-12
B108744POCTENUS0BTL CellutoneBTL INDUSTRIES LIMITEDIRO2017-01-12
07290103039004VSA-3000 Vibratory Sensory AnalazerMEDOC LTD.IRO2016-09-24
07290103039509VSA-3000 Vibratory Sensory AnalazerMEDOC LTD.IRO2016-09-24