FDA.reportPublic FDA data

Omron TENS Gel Refill

Primary DI
20073796752310
Brand
Omron TENS Gel Refill
Company
Omron Healthcare, Inc.
Model
PMGELCAN
Catalog number
PMGELCAN
Device description
Omron TENS Gel Refills are to be used with the OMRON TENS devices with heat.
Published
2020-01-08
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181992000Heat Pain ProOmron Healthcare, Inc.2018-11-09NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796752313PackageGS14In Commercial Distribution
20073796752310PackageGS16In Commercial Distribution
00073796752316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379675231310073796752313
2007379675231020073796752310
00073796752316000737967523160737967523160073796752316

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-634-4350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
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
true
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
00073796252601Silver, Upper Arm Blood Pressure MonitorBP52602026-05-26
00073796451004Omron MicroAir Vibrating Mesh NebulizerNE-U100NE-U1002018-10-22
00073796800147Omron CompAir Compressor NebulizerRE-C800KDRE-C800KD2020-08-03
00073796451226Omron Micro Air Vibrating Mesh NebulizerNE-U22VNE-U22V2017-05-17
00073796453305Omron CompAir Elite Compact Compressor NebulizerNE-C30NE-C302017-05-17
00073796458010Omron CompAir Compressor NebulizerNE-C801NE-C8012017-05-17
00073796458034Omron CompAir Mini-NebulizerNE-C803NE-C8032017-05-17
00073796760069Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
10073796760066Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
00073796736538Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
10073796736535Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
00073796343927Omron Small D-ring CuffHEM-CS24-BHEM-CS24-B2019-04-03
00073796725310Omron 5 Series Upper Arm Blood Pressure MonitorBP7250CANBP7250CAN2019-07-08
00073796735319Omron 7 Series Upper Arm Blood Pressure MonitorBP7350CANBP7350CAN2019-07-08
00073796745318Omron 10 Series Upper Arm Blood Pressure MonitorBP7450CANBP7450CAN2019-07-08
00073796893101Blood Pressure Monitor BP9310TBP9310T2022-07-01
00073796745530Omron Blood Pressure MonitorBP7455CAN-CD6BP7455CAN-CD62021-09-01
00073796100315Omron 3 Series Upper Arm Blood Pressure MonitorBP7100CANBP7100CAN2019-07-08
00073796146054AC Adapter for digital Blood Pressure UnitsHEM-ADPTW5HEM-ADPTW52016-09-16
00073796149079AC Adapter for HEM-907XLHEM-ADPT907HEM-ADPT9072016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNYN2026-05-27
06977159460037GYMMAXGymmax Technology (Shenzhen) Co., Ltd.NYN2026-04-24
06976287180336Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180343Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
04719872263029Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
04719872264132Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
06971712720125ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-12-10
00810140062697RENPHOJoicom CorporationNYN2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NYN2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NYN2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NYN2025-09-11
00810113683379DualPulse CompactManamed, Inc.NYN2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NYN2025-09-11
06971712720057NEOCARBONHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-08-31
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NYN2025-08-21
03770018808239actiTENSSUBLIMEDNYN2025-02-07
00092237626870TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626856TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626863TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
06924607702959Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702966Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702973Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702980Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17