FDA.reportPublic FDA data

Vive

Primary DI
00810113577197
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB3024WHT
Device description
60 Mode TENS Unit
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233092000Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)Chongqing Rob Linka Science and Technology Co., Ltd.2024-02-12NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113577194PackageGS136In Commercial Distribution
00810113577197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357719410810113577194
00810113577197008101135771978101135771970810113577197

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226442535ViveLVA3192BLK2026-10-23
00810226442856ViveSUP3191BLK12CT2026-10-23
00810226443136ViveLVA3198BLK2PAK2026-10-23
00810226443068ViveLVA1006GBU2026-10-22
00810226443075ViveLVA1006PBU2026-10-22
00810226443082ViveSUP3196BLKSM2026-10-22
00810226443099ViveSUP3196BLKLXL2026-10-22
00810226443037ViveMOB1170BLK2026-10-21
00810226443044ViveMOB1170PUR2026-10-21
00810226443051ViveMOB1170TAL2026-10-21
00810226442719ViveMOB1168GRYLTH2026-10-20
00810226442726ViveMOB1168GRYAC2026-10-20
00810226443006ViveSUP3194ORG362026-10-20
00810226443013ViveSUP3195BLKSM2026-10-20
00810226443020ViveSUP3195BLKLXL2026-10-20
00810226442825ViveSUP3190BLKS2026-10-15
00810226442832ViveSUP3190BLKM2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-10-13
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-29
08032625829843NerveOTXDOMINO SRLIPF2026-07-28
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
08809851470145WavefacialWEERO Co., Ltd.IPF2026-06-22
G345SL2000CIONICCionic, Inc.IPF2026-06-04
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
04048223122235Stim2GoPajunk GmbH MedizintechnologieIPF2026-05-21
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11