FDA.reportPublic FDA data

VEINOPLUS DVT

Primary DI
03701084900022
Brand
VEINOPLUS DVT
Company
AD REM TECHNOLOGY
Model
2.1
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072252000VEINOPLUS NEUROMUSCULAR STIMULATORAd Rem Technology Sarl2008-01-30IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701084900022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701084900022037010849000223701084900022

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure85 KiloPascal160 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit80.6 Degrees Fahrenheit
Storage Environment Atmospheric Pressure85 Degrees Fahrenheit160 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit80.6 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33 (0)142600022info@veinoplus.com

Regulatory Flags#

DUNS number
273234679
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701084900015VEINOPLUS2.12016-09-19
03701084900039VEINOPLUS SPORT2.12016-09-19
03701084900008VEINOPLUS PACK8x13 OVAL2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.IPF2026-06-04
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
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
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22
08032625822851GLOBUSDOMINO SRLIPF2024-10-17
08032625828037GLOBUSDOMINO SRLIPF2024-10-17
08032625829799GLOBUSDOMINO SRLIPF2024-10-17
08032625829805GLOBUSDOMINO SRLIPF2024-10-17