FDA.reportPublic FDA data

LOTFANCY

Primary DI
10697360273013
Brand
LOTFANCY
Company
TOP-RANK HEALTH CARE CO., LTD.
Model
11M-2229-S
Device description
Adhesive Electrodes
Published
2020-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10697360273013PackageGS112In Commercial Distribution
20697360273010PackageGS196In Commercial Distribution
06973602730016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1069736027301310697360273013
2069736027301020697360273010
06973602730016069736027300166973602730016

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06973602730047LOTFANCY11N-2261-Y2021-06-15
06973602730061HQX50502021-06-15
06973602730078HQX501002021-06-15
06973602730085Pain ManagementFAF2000FAF20002021-06-15
16973602730051Belifu50100-102021-06-15
16973602730006LOTFANCY11M-2234-X2020-09-27
16973602730020Health Mate Forever12020-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02