FDA.reportPublic FDA data

Upper Limbs Intelligent Feedback and Training System

Primary DI
06975343590010
Brand
Upper Limbs Intelligent Feedback and Training System
Company
Guangzhou Yikang Medical Equipment Industrial Co.,Ltd
Model
A2
Published
2026-05-14
Public version status
New
Distribution status
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
06975343590010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975343590010069753435900106975343590010

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis system, force-testing, portableA portable computerized device assembly with multiple force-sensing hardware designed for analysis of biomechanical/neuromuscular function by enabling performance of: 1) multiple functional strength tests using a variety of hardware (e.g., dynamometers, pinchmeters); or 2) strength testing with additional neuromuscular function testing (range of motion or pain/touch sensitivity) using additional hardware (e.g., goniometer, algometer). The system is typically designed so results can be displayed on an off-the-shelf computer/smartphone. It is not intended for interactive gaming and is not primarily based on analysing movement through motion sensing (i.e., not a kinesiology system).

Regulatory Flags#

DUNS number
420787643
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
06975343590027Lower Limbs Intelligent Feedback and Training SystemA1S2026-05-14
06975343590034Gait Training and Evaluation SystemA3-M2026-05-14
06975343590041Multi-joint isokinetic training and testing systemA8-32026-05-14
06975343590058Multi-joint isokinetic training and testing systemA8mini12026-05-14
06975343590065Multi-joint isokinetic training and testing systemA8mini22026-05-14
06975343590072Upper Limbs Training and Evaluation SystemA6m12026-05-14
06975343590089Upper Limbs Training and Evaluation SystemA6m22026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenA1mini Deer version2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenA1miniS Deer version2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemA2-22026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenA1miniS Hippo version2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenHippo version2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenA1miniS Rocket version2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenA1mini Rocket version2026-05-14
06975343590218Gait Training and Evaluation SystemA3-22026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentSL42026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentSL4-3M2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentSL4I-12026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentSL4I-22026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810188050021Bioness Integrated System (BITS) Bedside ConfigurationBioness Medical, Inc.IKK2025-07-18