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Johari Digital Healthcare Ltd.
SYRMA JOHARI MEDTECH LIMITED · Model Myolift TW · UDI-DI 08908008085437
1
510(k) clearances
37
Adverse events
2
Recalls
60
Facilities
Description
"MYOLIFT Triwave 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 channeled to the facial muscles through two applicator probes, re-educating & strengthening the muscle. MYOLIFT Triwave 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"
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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Get your free API keyRead the docsData 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.