FDA.reportPublic FDA data

VQ ORTHOCARE

Primary DI
00817717020197
Brand
VQ ORTHOCARE
Company
Vision Quest Industries Incorporated
Model
55-95003-201
Device description
BIONICARE KNEE SYSTEM LEFT S/M
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K030332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030332000MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000Bionicare Medical Technologies, Inc.2003-06-06NYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817717020197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817717020197008177170201978177170201970817717020197

GMDN Terms#

Term, Definition table
TermDefinition
Arthritis transcutaneous electrical joint stimulation systemAn assembly of battery-powered devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating arthritic tissue in a joint across the skin (transcutaneously); it is not intended for neurostimulation. It typically consists of an external electric current generator and electrodes (leads) that are placed on the skin with conductive patches to deliver pulsed electrical fields to the painful arthritic tissue. It is intended for routine home-use to treat symptoms of rheumatoid arthritis (RA) of the hands and osteoarthritis of the knee.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791122422
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
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
00817717023099VQ OrthoCarePL-029K26-VQ2024-03-28
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

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Primary DI, Brand, Company table
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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
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00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NYN2025-09-11
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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
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06924607702959Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
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06924607702973Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
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