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Lotfancy

FDA UDI

Class II (US FDA UDI)

by Top-Rank Health Care Co., Ltd.

Identity

Trade Name
LOTFANCY FDA UDI
Generic Name
Transcranial electrical stimulation system, pulsed-current FDA UDI
Device Name
Adhesive Electrodes FDA UDI
Model / Reference
11M-2229-S FDA UDI
Description
Adhesive Electrodes FDA UDI

Identifiers

Primary DI / UDI-DI
06973602730016 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
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

Yes

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

Category: Transcranial electrical stimulation system, pulsed-current

Lotfancy by Top-Rank Health Care Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcranial electrical stimulation system, pulsed-current.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Top-Rank Health Care Co., Ltd.

Sources (1)

  • FDA UDI 44d3615d-2f3d-4c32-9bac-d27fbf4978b3 33 fields · synced May 30, 2026