FDA.reportPublic FDA data

VQ OrthoCare

Primary DI
00817717021811
Brand
VQ OrthoCare
Company
Vision Quest Industries Incorporated
Model
AV-IF19A
Device description
Avid IF2 INTERFERENTIAL STIMULATION SYSTEM
Published
2020-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183692000Avid IF2Vision Quest Industries Inc./Dba VQ Orthocare2019-06-12LIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817717021811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817717021811008177170218118177170218110817717021811

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.

Contacts#

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

Regulatory Flags#

DUNS number
791122422
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00817717023099VQ OrthoCarePL-029K26-VQ2024-03-28
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
00817717020500VQ ORTHOCARE08-22008-0022022-03-19
00817717020517VQ ORTHOCARE08-22998-0012022-03-19
00817717020524VQ ORTHOCARE08-22998-0022022-03-19
00817717020531VQ ORTHOCARE08-32006-0012022-03-19
00817717020548VQ ORTHOCARE08-32006-0022022-03-19
00817717020555VQ ORTHOCARE08-32996-0012022-03-19
00817717020562VQ ORTHOCARE08-32996-0022022-03-19
00817717020579VQ ORTHOCARE08-32008-0012022-03-19
00817717020586VQ ORTHOCARE08-32008-0022022-03-19
00817717020593VQ ORTHOCARE08-32998-0012022-03-19
00817717020609VQ ORTHOCARE08-32998-0022022-03-19
00817717020616VQ ORTHOCARE07-41003-0012022-03-19
00817717020623VQ ORTHOCARE07-41004-0012022-03-19
00817717020630VQ ORTHOCARE07-42203-0012022-03-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
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03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNYN2026-05-27
06977159460037GYMMAXGymmax Technology (Shenzhen) Co., Ltd.NYN2026-04-24
06976287180336Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180343Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
04719872263029Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
04719872264132Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
06971712720125ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-12-10
00810140062697RENPHOJoicom CorporationNYN2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NYN2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NYN2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NYN2025-09-11
00810113683379DualPulse CompactManamed, Inc.NYN2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NYN2025-09-11
06971712720057NEOCARBONHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-08-31
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NYN2025-08-21
06971712720583Smart-Wave Knee RehabHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-08-05
03770018808239actiTENSSUBLIMEDNYN2025-02-07
00092237626870TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626856TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
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