FDA.reportPublic FDA data

Vive

Primary DI
10810041989601
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB2029PAK2
Device description
Replacement Electrodes for Wireless TENS Unit (2PK)
Published
2022-07-27
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
true

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
10810041989601PackageGS1100In Commercial Distribution
00810041989604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198960110810041989601
00810041989604008100419896048100419896040810041989604

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00810178883943ViveSUP3111BLK2026-03-06
00810178884506ViveMOB1141BLK322026-03-06
00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594795Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
08057971594801Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
08057971594818Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
B195XC813waveguardeemagine Medical Imaging Solutions GmbHGXY2026-03-19
03615220004355Neuronaute IceCap 2 SmallBIOSERENITY MEDICAL DEVICES GROUPGXY2026-03-17
00860008546005Nexalin ADINEXALIN TECHNOLOGYGXY2026-03-16
09342451004772Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-03
00850080988121AUVONUAN HEALTHCARE LIMITEDGXY2026-03-02
09342451003904Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003980Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003997Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004000Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004017Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004024Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004031Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004314Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004611Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004628Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004635Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004642Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004659Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004673Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004680Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004697Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004703Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004710Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004727Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004734Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004741Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004758Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02