FDA.reportPublic FDA data

Revitive Electrode Body Pads

Primary DI
05060217492130
Brand
Revitive Electrode Body Pads
Company
ACTEGY LIMITED
Model
2044
Published
2021-05-04
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

Contact Domains#

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
05060217490310PackageGS110In Commercial Distribution
05060217492130PackageGS1300In Commercial Distribution
05060217490303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060217490310050602174903105060217490310
05060217492130050602174921305060217492130
05060217490303050602174903035060217490303

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn 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 (EMS), 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-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Degrees Fahrenheit80 Degrees Fahrenheit
Handling Environment Temperature32 Degrees Fahrenheit102 Degrees Fahrenheit
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit102 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8772603114us.info@actegy.com

Regulatory Flags#

DUNS number
735575941
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
true
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
00858058005108Revitive EssentialRLV24522020-09-24
00858058005184Revitive Medic Knee2836AB57372020-09-24
00858058005221Revitive Medic Coach5575AQ59212022-01-28
00858058005238Revitive Medic5573AQ59702021-01-19
00858058005252Revitive ProHealth5572AQ63022021-01-21
10858058005228Revitive Medic Coach5575AQ59212022-01-28
05060217490303Revitive Electrode Body Pads20442021-05-04
05060217493571Revitive Arthritis Knee Pads293929392020-07-28
00858058005047Aerosure3481AJ14742021-05-04
10858058005044Aerosure3481AJ14742021-05-04
00858058005023Revitive Electrode Body Pads157015702018-04-23
10858058005259Revitive ProHealth5572AQ63022021-01-21
10858058005235Revitive Medic5573AQ59702021-01-19
10858058005105Revitive EssentialRLV24522020-09-24
10858058005181Revitive Medic Knee2836AB57372020-09-24
05060217493588Revitive Arthritis Knee Pads293929392020-07-28
00858058005146Revitive Medic Plus3156AD31582019-10-09
10858058005143Revitive Medic Plus3156AD31582019-10-09
00858058005016Revitive Circulation BoosterRIX17182018-04-23
00858058005085Revitive Medic2469MD26162018-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
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