FDA.reportPublic FDA data

FyneLook

Primary DI
06973602730795
Brand
FyneLook
Company
TOP-RANK HEALTH CARE CO., LTD.
Model
TG01-70
Device description
Conductive gel
Published
2025-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222770000Conductive GelTop-Rank Health Care Co., Ltd.2022-12-13GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973602730795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973602730795069736027307956973602730795

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

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
06973602730849EZ MED SUPPLIESWF2030WF20302026-01-06
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
10697360273013LOTFANCY11M-2229-S2020-09-27
16973602730020Health Mate Forever12020-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09342451003416Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003423Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003430Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003447Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
00197998355363Solventum™Solventum US LLCGYB2026-02-15
00197998355400Solventum™Solventum US LLCGYB2026-02-15
00197998355370Solventum™Solventum US LLCGYB2026-02-15
00197998355417Solventum™Solventum US LLCGYB2026-02-15
06974667824986JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06974667824993JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06974667825006JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667824983JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667824990JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667825003JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06973602730627MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-04-23
06973602730610MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-03-18
00850024089235MedvatMyt Enterprises LLCGYB2025-02-19
00840295408224TherabodyTherabody, Inc.GYB2025-01-26
B1870800TheraMistNEUROTRON MEDICAL, INC.GYB2024-12-04
06971292004011AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-29
16971292006739AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
16971292006746AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
26971292006736AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
26971292006743AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
04260280180335AxionAxion USA LLCGYB2024-03-18
04262356159993EEG-acpCNSAC Medshop GmbHGYB2024-01-22
B311PEHTNPDS20PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
B311PEHTNPDS50PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
00850021097561Nu Skin RenuSpa iO PackageNSE PRODUCTS, INC.GYB2023-11-27
10855683006545UltradrapePARKER LABORATORIES INCGYB2023-09-18