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Johari Digital and 7e Wellness Celebrate US-FDA 510k Clearance of Myolift QT Device as OTC

05-02-2023 09:13 AM CET | Health & Medicine

Press release from: Johari Digital Healthcare Limited

Johari Digital an medical device manufacturer and 7e Wellness Celebrate US-FDA 510k Clearance of Myolift QT Device as OTC

Johari Digital an medical device manufacturer and 7e Wellness Celebrate US-FDA 510k Clearance of Myolift QT Device as OTC

Johari Digital Healthcare Ltd, the manufacturing partner of 7e Wellness is glad to share that 7e's Myolift QT has cleared US FDA (510k) for OTC.

The device is indicated for Facial and Neck stimulation along with over-the-counter cosmetic uses. The clearance also includes Mobile APP, which gives the device a huge competitive edge. Additionally, four Electrodes and Conductive gloves are included in the application.

"Teams from Johari & 7e Wellness worked hard with perseverance and dedication to achieve this clearance. The clearance gives 7e a big Launchpad to push and market Myolift QT in the US & rest of the world." - Pooja Johari, CPO & Founder, 7e Wellness

About Myolift QT
Myolift QT makes professional skincare portable. The Micro current Facial Device comes with Anti-aging Peptide Serum Smart Current Technology & Smartphone App. The Micro current waves from the device imitate the user's natural energy current to regenerate the cells & boost ATP, elastin & collagen production giving a glowing youthful appearance. The device has been so far a great success in providing toned, firmer, and blemish-free skin.

About 7e-Johari Manufacturing Partnership
7e's Myolift range comprises of- Mini, 600, QT & Triwave. Johari Digital has a 15 yrs. ongoing relationship with 7e Wellness where they have worked on the Design & Manufacturing of Myolift devices with a key focus on,

• Industrial Design
• Mechanical Design
• Electronics Design
• Software Design
• Regulatory Assistance [US FDA (510k)]

The devices are a benchmark in their domain. Feedback from end users, stakeholders, designers & developers has played a crucial role in transforming the design & functionality for more impactful treatment.

"Proud of Johari team and persuasion of 7e who believed in the team. I am sure with this one product, 7e will be able to grow and reach out to a huge number of customers." - Mrs. Nisha Johari, MD, Co-Founder, Johari Digital Healthcare Ltd.

Working with 7e Wellness over the years, the Johari team has been successful in reducing the cost of manufacturing to ensure the affordability of the product for the majority of users across the globe.

Company: Johari Digital Healthcare Limited
Address: G-582-584, EPIP, Boranada - Rajasthan - 342012, India.
Email: kkumawat@joharidigital.com
Contact: +91 9549687555
Website: https://www.joharidigital.com/

Johari Digital is a global MedTech company with 40+ years of expertise in medical device manufacturing. The manufacturing facility is in compliance with MDSAP, ISO 13485:2016 and FDA (21 CFR 820) standards and processes. Their services range from design to development, electronics and mechanical engineering, prototyping, system integration, packaging and supply chain. Additionally, Johari also helps clients with regulatory and compliance support to quickly take their product to market.

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