FDA.reportPublic FDA data

MJS System 3 Upgrade

Primary DI
00718175004050
Brand
MJS System 3 Upgrade
Company
SPORT MEDICAL TECHNOLOGY INC.
Model
850-820
Catalog number
850-820
Device description
BIODEX SYSTEM 3 REMANUFACTURE
Published
2017-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKKSystem, Isokinetic Testing And Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175004050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175004050007181750040507181750040500718175004050

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/interactive rehabilitation systemA computerized device assembly designed for: 1) analysis of biomechanical/neuromuscular function using dedicated hardware; and 2) neuromuscular rehabilitation therapy at multiple anatomical sites based on patient interaction with dedicated physical-response measuring hardware (e.g., dynamometer, standing force plates, EMG electrodes) providing feedback in a videogame-like format. It includes multiple pieces of neuromuscular function analysis and physical-response measuring hardware, computer interface devices and dedicated software; it is intended to be used with an off-the-shelf computer. It is not based on tracking movement through space (i.e., not a virtual-display rehabilitation system).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145217304
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175002407Biostep 2, 100-240 VAC950-2402024-05-06
00718175006009Reactive Step Trainer 115V950-6002024-05-06
00718175001462Biodex950-146950-1462023-08-02
00718175001486Biodex950-148950-1482023-08-02
00718175005606Sit2Stand950-560950-5602023-07-31
00718175004302VibroTactile950-4302023-07-19
00718175004807NxSTEP945-480945-4802019-05-15
00718175004845NxSTEP950-484950-4842019-05-15
00718175005705MOBILITY ASSIST950-570950-5702019-06-10
00718175004852NxSTEP950-485950-4852019-04-30
00718175000038BALANCE SD950-440950-4402018-06-30
00718175000045BALANCE SD950-441950-4412018-06-30
00718175000052BALANCE SD950-444950-4442018-06-30
00718175000120BIOSWAY 950-460950-4602018-06-30
00718175004005System 4 Pro850-000850-0002017-12-18
00718175004067MJS System 3 Upgrade850-822850-8222018-08-10
00718175004203System 4 Quick Set840-000840-0002017-12-18
00718175004401System 4 MVP852-000852-0002017-12-18
00718175005408Gait Trainer 3950-400950-4002018-04-15
00718175005415Gait Trainer 3950-401950-4012018-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975343590010Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590027Lower Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590034Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590041Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590058Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590065Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590072Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590089Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590218Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
04041925006339PHS - XSmedica - Medizintechnik GmbHIKK2026-05-13
04041925006346PHS - Smedica - Medizintechnik GmbHIKK2026-05-13
04041925006353PHS - Mmedica - Medizintechnik GmbHIKK2026-05-13
04041925006360PHS - Lmedica - Medizintechnik GmbHIKK2026-05-13
04041925006377PHS - XLmedica - Medizintechnik GmbHIKK2026-05-13
B108660POMUS00R-GAITBTL INDUSTRIES LIMITEDIKK2026-03-19
09120077180250LEXOtyromotion GmbHIKK2026-03-12
06979351820015Upper Limb Rehabilitation Training SystemShanghai ZDROID Medical Technology Co.,Ltd.IKK2025-12-23
05061081950009LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
05061081950184LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03