FDA.reportPublic FDA data

VQ OrthoCare

Primary DI
00817717023099
Brand
VQ OrthoCare
Company
Vision Quest Industries Incorporated
Model
PL-029K26-VQ
Device description
PRO eStim NMES Stimulator
Published
2024-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
IPFStimulator, Muscle, Powered
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182203000JKH Stimulator PlusJkh USA, LLC2019-03-14NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817717023099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817717023099008177170230998177170230990817717023099

GMDN Terms#

Term, Definition table
TermDefinition
Interferential electrical stimulation systemAn electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
760-691-0168mouerghi@vqorthocare.com

Regulatory Flags#

DUNS number
791122422
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817717020128VQ ORTHOCARE55-90000-0012017-07-05
00817717020135VQ ORTHOCARE55-92000-2012017-07-05
00817717020142VQ ORTHOCARE55-92000-3012017-07-05
00817717020159VQ ORTHOCARE55-92000-4012017-07-05
00817717020166VQ ORTHOCARE55-92000-5012017-07-05
00817717020173VQ ORTHOCARE55-92000-6012017-07-05
00817717020180VQ ORTHOCARE55-92000-7012017-07-05
00817717020197VQ ORTHOCARE55-95003-2012017-07-05
00817717020203VQ ORTHOCARE55-95003-3012017-07-05
00817717020210VQ ORTHOCARE55-95003-4012017-07-05
00817717020227VQ ORTHOCARE55-95004-2012017-07-05
00817717020234VQ ORTHOCARE55-95004-3012017-07-05
00817717020241VQ ORTHOCARE55-95004-4012017-07-05
00817717021668VQ ORTHOCARE55-92000-9992018-03-22
00817717022061VQ OrthoCareAV-CT20A2022-03-19
00817717020456VQ ORTHOCARE08-22006-0012022-03-21
00817717020463VQ ORTHOCARE08-22006-0022022-03-19
00817717020470VQ ORTHOCARE08-22996-0012022-03-19
00817717020487VQ ORTHOCARE08-22996-0022022-03-19
00817717020494VQ ORTHOCARE08-22008-0012022-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
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 SRLLIH2026-02-23
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22
08032625822851GLOBUSDOMINO SRLIPF2024-10-17
08032625822851GLOBUSDOMINO SRLLIH2024-10-17
08032625828037GLOBUSDOMINO SRLLIH2024-10-17
08032625828037GLOBUSDOMINO SRLIPF2024-10-17
08032625829799GLOBUSDOMINO SRLLIH2024-10-17
08032625829799GLOBUSDOMINO SRLIPF2024-10-17
08032625829805GLOBUSDOMINO SRLIPF2024-10-17
08032625829805GLOBUSDOMINO SRLLIH2024-10-17
08032625829812GLOBUSDOMINO SRLLIH2024-10-17
08032625829812GLOBUSDOMINO SRLIPF2024-10-17