Proud Manufacturer of FDA Compliant Medical Devices
Johari Digital has become one of the largest manufacturer of physiotherapy and medical aesthetic Devices. From 40 years, Johari Digital has been innovating and developing health benefiting technologies and manufacturing solutions. It is one of the first Indian Manufacturer of FDA Compliant Medical Device. The first company to get US FDA clearance for their electro-medicine device in 1986 and further continued to get more than 15 products FDA certified for professionals in physical therapy and medical aesthetic, sports medicine and neuro-rehabilitation.
The manufacturing facility is FDA, GMP and MDSAP certified with a state of the art class 100,000 clean room. Having spent 40 years in medical manufacturing, we have bench-marked our process to the highest standards, as a result we have accumulated a lot of certifications, and recognition for our expertise and excellence. Our bestselling healthcare devices attest our innovation and high standards.
Highlights of Pre-market Submission – 510(k) / PMA
In 1989, we received first 510(k) clearance for Class II medical device – Transcutaneous Electrical Nerve Stimulator.
In 2009, we have received our first 510(k) clearance for a class III medical device.
Today, we have received fifteen 510(k) clearances – Class II, III OTC (Over The Counter) under Johari ownership and additional ten 510(k) clearances for our clients.
Your FDA Compliant Global MedTech Partner
With a state-of-the-art manufacturing setup located in India, a dedicated R&D center in Europe and a distribution center in the US, Johari Digital is strategically positioned to serve business partners around the globe. Our FDA registered medical devices meet every benchmark of international quality standards.
Technologies & Product Offerings
With 100,000+ product installations worldwide, Johari’s expertise in medical device manufacturing cuts across industries. We have received FDA clearance in following technologies:
Combination Therapy: Our Combo-therapy is 510(k) cleared which includes combination of Ultrasound and electrotherapy. It includes all the major currents like TENS, IFT, EMS, Russian, Galvanic, etc.
Ultrasound Therapy: Ultrasound therapy with 1 & 3MHz is also FDA Registered Medical Device particularly used for pain management.
Electrotherapy: All the currents that helps is pain management including TENS, IFT, EMS, Russian, Galvanic, etc. are FDA cleared.
CES (Cranial Electro-Stimulation) Therapy: One of the trending technology for stress relief is safe, effective and 510(k) cleared.
Bio-electrical Stimulation: An important technology for body shaping and weight loss management. It is 100% non-invasive, pain-free and 510(k) cleared.