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Sign in to claim this brandSYRMA JOHARI MEDTECH LIMITED
US
Last updated May 27, 2026
What SYRMA JOHARI MEDTECH LIMITED makes
The company manufactures neuromuscular electrical stimulation systems for physical therapy, including line-powered units and combined ultrasound/neuromuscular stimulation devices. It also produces single-use transcutaneous electrical stimulation electrodes and stereotactic neuronavigation/planning systems for surgical planning and guidance.
These products are regulated under FDA classifications, with some devices authorised as Class II and others as Class III. They are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with US medical device regulations. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Syrmia Johari MedTech Limited manufacture?
Syrmia Johari MedTech Limited specializes in neuromuscular electrical stimulation systems designed for physical therapy. These include line-powered units, systems combining ultrasound with neuromuscular stimulation, and single-use transcutaneous electrical stimulation electrodes. Additionally, the company produces stereotactic neuronavigation/planning systems, which assist in surgical planning and guidance by providing precise spatial mapping for procedures.
Where is Syrmia Johari MedTech Limited based, and how does this affect its regulatory oversight?
Syrmia Johari MedTech Limited is based in the United States, which means its devices are subject to FDA regulations. The company’s products appear in the FDA’s 510(k) and UDI registries, indicating compliance with US medical device requirements. The FDA classifies these devices as either Class II or Class III, depending on their risk level and intended use.
Which regulatory registries list Syrmia Johari MedTech Limited’s devices, and why?
Syrmia Johari MedTech Limited’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry includes devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, while the UDI (Unique Device Identification) registry ensures traceability and transparency in the supply chain by assigning a unique identifier to each device type.
How are Syrmia Johari MedTech Limited’s devices classified under FDA regulations?
Syrmia Johari MedTech Limited’s devices are classified as either Class II or Class III under FDA regulations. Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require premarket approval (PMA) due to insufficient data from 510(k) pathways. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- joharidigital.com
- —
- —
- [email protected]
- Phone
- 982-805-4228
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 675938472
Catalogue (49)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Johari Digital Healthcare Ltd. | MyoBody XT | FDA UDI | Class II | Active |
| 7E Wellness | TORC BODY | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | STIM TENS | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | WSU | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | Sonicaor Plus 941 | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | Myolift TW | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | Sonicaor Plus 921 | FDA UDI | Class II | Active |
| 7E Wellness | MYOLIFT | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | INTERSPEC-IF II | FDA UDI | Class II | Active |
| Unidever | Libido Machine | FDA UDI | Class II | Active |
| Mettler Electronics Corp. | SYSSTIM 208/208A | FDA UDI | Class II | Active |
| Medi Stim Inc. | ALL STIM(MINI) | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | MYOLIFT 600+ | FDA UDI | Class II | Active |
| Seven Seas Distribution and Manufacturing, LLC | X FORCE | FDA UDI | Class II | Active |
| 7E Wellness | Myocalme RC | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | ISLIM | FDA UDI | Class II | Active |
| Medi Stim Inc. | ALL STIM | FDA UDI | Class II | Active |
| 7e Wellness | Myorelief | FDA UDI | Class II | Active |
| 7E Wellness | MYOLIFT ULTRA | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | NMS498 | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | truFlex | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | AP-439 | FDA UDI | Class II | Active |
| 7E Wellness | MY-O-CALME | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | Zeta Cranial Navigation System | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | JUS2 | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | TENS 250 | FDA UDI | Class II | Active |
| HILL Laboratories Company | HILL IFC Interferential Unit | FDA UDI | Class II | Active |
| Syrma Johari MedTech Limited | Myolift QT+ | FDA UDI | Class II | Active |
| Seven Seas Distribution and Manufacturing, LLC | PRO-TECH MULTI STIM | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | truSculpt Flex | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | Myolift 600 | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | MINDGEAR | FDA UDI | Class III | Active |
| Johari Digital Healthcare Ltd. | Nishcalm RC | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | WS4U-Combo Device | FDA UDI | Class II | Active |
| TONE-A-MATIC International Incorporated | TDR68 TAMI | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | Neuro-M Trainer Model A | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | Myolift QT | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | X Trainer | FDA UDI | Class II | Active |
| Solace Lifesciences, Inc | NUCALM | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | Neubie | FDA UDI | Class II | Active |
| HILL Laboratories Company | HF54 | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | WS2U-Combo Device | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | StimTec 2ch/4ch | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | J-STIM2/4 | FDA UDI | Class II | Active |
| Johari Digital Healthcare Limited | STIM3 | FDA UDI | Class II | Active |
| BioMedical Life Systems, | Bio Med Fit | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | truSculpt Flex retractable electrode assembly | FDA UDI | Class II | Active |
| Johari Digital Healthcare Ltd. | IF4250D | FDA UDI | Class II | Active |
| truFlex | K251594 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Syrma Johari MedTech Limited Jodhpur Rajasthan · IN FEI 3005154439