FDA.reportPublic FDA data

LOTFANCY

Primary DI
06973602730047
Brand
LOTFANCY
Company
TOP-RANK HEALTH CARE CO., LTD.
Model
11N-2261-Y
Device description
GEL PAD
Published
2021-06-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973602730047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973602730047069736027300476973602730047

GMDN Terms#

Term, Definition table
TermDefinition
Transcranial electrical stimulation system, pulsed-currentA noninvasive assembly of mains electricity (AC-powered) devices designed to apply weak, pulsed (not continuous) electrical stimuli to a patient's brain to treat one or more psychiatric disorders which may include anxiety, depression, insomnia, and/or addiction; it may also be intended to induce a state resembling that of chemically-induced anaesthesia. It usually includes an electrical pulse generator with controls to vary the pulse rate, pulse width, and voltage or current, with the current applied via leads and appropriate scalp electrodes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529504164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973602730894MEDLOT12W-3527-Q.LA2026-06-08
06973602730849EZ MED SUPPLIESWF2030WF20302026-01-06
06973602730795FyneLookTG01-702025-10-23
06973602730696reajoyTENS806-202025-08-21
06973602730702reajoyTENS806-402025-08-21
06973602730719reajoyTOPTENS-012025-08-21
06973602730627MedvatMED-USG-TR-CLEAR-22-2PK-A2025-04-23
06973602730610MedvatMED-USG-TR-CLEAR-22-2PK-A2025-03-18
06973602730009LOTFANCY11M-2234-X2020-09-27
06973602730016LOTFANCY11M-2229-S2020-09-27
06973602730023Health Mate Forever12020-09-27
06973602730054Belifu50100-102021-06-15
06973602730061HQX50502021-06-15
06973602730078HQX501002021-06-15
06973602730085Pain ManagementFAF2000FAF20002021-06-15
16973602730051Belifu50100-102021-06-15
16973602730006LOTFANCY11M-2234-X2020-09-27
10697360273013LOTFANCY11M-2229-S2020-09-27
16973602730020Health Mate Forever12020-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378363Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378394Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378400Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378417Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08