Identity
- Trade Name
- LOTFANCY FDA UDI
- Generic Name
- Transcranial electrical stimulation system, pulsed-current FDA UDI
- Device Name
- GEL PAD FDA UDI
- Model / Reference
- 11N-2261-Y FDA UDI
- Description
- GEL PAD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973602730047 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcranial electrical stimulation system, pulsed-current FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Lotfancy by Top-Rank Health Care Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Top-Rank Health Care Co., Ltd.
Sources (1)
- FDA UDI 5f834404-9a4f-46ca-9a62-5884bb580b6e 34 fields · synced Jun 1, 2026