Identity
- Trade Name
- Johari Digital Healthcare Ltd. FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MINDGEAR FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908008085406 FDA UDI
- 510(k) Number
- K090052 FDA UDI
- FDA Product Code
- JXK FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 882.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Johari Digital Healthcare Ltd. by Syrma Johari Medtech Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Syrma Johari Medtech Limited
Sources (1)
- FDA UDI f9411334-921e-4b2e-a073-4f848d246d42 35 fields · synced May 30, 2026