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Johari Digital Healthcare Ltd.

SYRMA JOHARI MEDTECH LIMITED · Model Myolift QT · UDI-DI 08908008085369

510(k) clearances

Adverse events

Recalls

Facilities

Description

MYOLIFT QT is a device based on true micro-current technology and one of the most advanced personal facial toning devices on the market. Its gentle, non-invasive electrical impulses are evenly channelled to the facial muscles through two applicator probes, re-educating & strengthening the muscle. MYOLIFT QT is portable device powered from the built-in battery or external power supply. The battery charger which is the integral part of device provides the fast and effective charging process. MYOLIFT QT is a portable device with Blue-Tooth (BT) connectivity with simple user- interface where the full control of device is provided through BT. Some simple actions and major indications can be achieved by using the interfaces which are built-in in device

Recalls

Date	Firm	Reason
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.