FDA.reportPublic FDA data

Vive

Primary DI
10861470000399
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB1006BLK
Device description
Tens Unit Black
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10861470000399PackageGS120In Commercial Distribution
00861470000392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086147000039910861470000399
00861470000392008614700003928614700003920861470000392

GMDN Terms#

Term, Definition table
TermDefinition
Intramuscular injection site nerve-locating/electromyography systemA portable, electrically-powered device intended to produce electrical impulses for electrical nerve stimulation and to obtain and display electromyography (EMG) readings (visual and/or audio) to locate nerves and muscle, to facilitate accurate intramuscular injection of neuromodulator drugs. It is typically used in multi-focal areas (e.g., neck, hand), and consists of an electrical stimulator with EMG reader in a noninvasive unit (electrodes not included) which typically includes input cables and connectors.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
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
true
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
06971712727704YUN MANSIONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-26
00850080988466AUVONUAN HEALTHCARE LIMITEDNUH2026-05-24
06932307410418JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.NUH2026-03-04
00714905710024Fab StimCOMPASS HEALTH BRANDS CORP.NUH2026-02-06
06971292004301AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2026-01-21
00850016867407Pixie CupPixie Cup LLCNUH2026-01-09
06971292004295AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-12-17
00810093080786PainPod Hi-Dow International IncorporatedNUH2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNUH2025-12-09
04719871185605iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
04719871186039EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
16978452680020EPULSEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
16978452680037KONGZEEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
06971292004127AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-22
10850073128180AVCOOADP HEALTH LIMITEDNUH2025-09-19
10850073128197AVCOOADP HEALTH LIMITEDNUH2025-09-19
16971292004117AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-19
10850073128166AVCOOADP HEALTH LIMITEDNUH2025-09-18
06971292004103AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-11
16971292008078AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-02
16970890320681AUVONShenzhen As-Tec Technology Co.,Ltd.NUH2025-08-30
00850073128121AVCOOADP HEALTH LIMITEDNUH2025-08-25
10850073128135AVCOOADP HEALTH LIMITEDNUH2025-08-25
06973602730719reajoyTOP-RANK HEALTH CARE CO., LTD.NUH2025-08-21
16978452680013NURSALShenzhen Jiantuo Electronics Co., LtdNUH2025-08-21
06971292008064AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-08-12
16971712724717UnimedHong Qiangxing (Shen Zhen) Electronics LimitedNUH2025-08-11
00851221006803Quell 2.0NEUROMETRIX, INC.NUH2025-08-01
16978146200107SinrelSHENZHEN SINREL TECH LTDNUH2025-07-14
04251784906101HealyHealy GmbHNUH2025-07-10