FDA.reportPublic FDA data

Home Care

Primary DI
04719873684557
Brand
Home Care
Company
HOME CARE TECHNOLOGY CO., LTD.
Model
JELLY 4000G
Device description
Electroconductive(Electrode Gel)
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K022494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022494000HOME CARE JELLYRoc Chinese-European Industrial Research Society2002-12-02GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873684557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873684557047198736845574719873684557

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658105861
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873683208Home CareHT 3112016-12-31
04719873683215Home CareHT 326L2016-12-31
04719873683307Home CareHT 329L2(M2)2016-12-31
04719873683314Home CareHT329L3(M3)2016-12-31
04719873683321Home CareHT 329L4(M4)2016-12-31
04719873683338Home CareHT 329L1(M1)2016-12-31
04719873684540Home CareJELLY 250G2016-12-31
04719873684328Home CareGEL PAD 1.5 x 9cm (R)2017-08-30
04719873684724Home CareFA40402016-12-31
04719873684755Home CareFA50502016-12-31

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
06973602730795FyneLookTOP-RANK HEALTH CARE CO., LTD.GYB2025-10-23
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