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Johari Digital Healthcare Ltd.
SYRMA JOHARI MEDTECH LIMITED · Model MINDGEAR · UDI-DI 08908008085406
1
510(k) clearances
21
Adverse events (1 deaths)
3
Recalls
5
Facilities
Description
Mindgear is cranial electrotherapy device and it is indicated for use CES for the treatment of insomnia and anxiety. Key Features: 510(K) cleared device, Portable and user-friendly device, Used for the treatment of insomnia and anxiety.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-10-29 | Neuro-Fitness LLC | No FDA clearance for the .35Hz/.45Hz frequency option on device. |
| 2007-07-19 | Health Directions, Inc | Peak voltage test result not in acceptable limits. |
| 2004-04-08 | Health Directions, Inc | Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device |
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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.