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Data / Medical devices / System, Isokinetic Testing And Evaluation

System, Isokinetic Testing And Evaluation (IKK): 52 FDA-registered makers in 15 countries

52 establishments in 15 countries are registered with the FDA to make System, Isokinetic Testing And Evaluation (product code IKK, Class 2, 21 CFR 890.1925). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 61 510(k) clearances under this code, the latest on May 24, 2013, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
IKK
Device class
2
Regulation
890.1925
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States19
China9
South Korea8
United Kingdom4
Singapore2
Bulgaria1
Israel1
Hong Kong1
France1
Spain1
Netherlands1
Germany1
Italy1
India1
Austria1

Makers of System, Isokinetic Testing And Evaluation

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Activinsights Ltd.Kimbolton Cambridgeshire, United KingdomComplaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer0000api.fda.gov
Articares Pte LtdSINGAPORE Central Singapore, SingaporeManufacturer, Specification developer0000api.fda.gov
Assistive Technology Development, Inc.Orange, CA, United StatesManufacturer0000api.fda.gov
Barrett Technology, LLCNewton, MA, United StatesManufacturer0000api.fda.gov
Bertec Corp.Columbus, OH, United StatesManufacturer0000api.fda.gov
Bioliberty LtdEdinburgh Edinburgh, City of, United KingdomSpecification developer0000api.fda.gov
Biometrics Ltd.Newport Wales, United KingdomManufacturer0000api.fda.gov
Bioness Medical, Inc.Valencia, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Bte TechnologiesHanover, MD, United StatesManufacturer0000api.fda.gov
BTL Industries JSCPlovdiv, BulgariaManufacturer0000api.fda.gov
Bioventus LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Bioxtreme Ltd.Petach Tikva Central, IsraelManufacturer0000api.fda.gov
Changsha Jinuo Intelligent Technology Co., Ltd.Changsha Hunan, ChinaManufacturer0000api.fda.gov
Computer Sports Medicine, Inc.Stoughton, MA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Cosmo Robotics Co., LtdSeoul, South KoreaManufacturer0000api.fda.gov
CUREXO, Inc.Songpa-gu Seoul, South KoreaManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Defond Electech Co., LtdDongguan, Hong KongContract manufacturer0000api.fda.gov
Figur8, Inc.Boston, MA, United StatesManufacturer0000api.fda.gov
Fourier Intelligence Inc.Shanghai, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Guangzhou Yikang Medical Equipment Industrial Co.,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
H Robotics Inc.Yeonsu-gu Incheon, South KoreaManufacturer0000api.fda.gov
Healing InnovationsNashville, TN, United StatesManufacturer0000api.fda.gov
Hue Light Co., LtdGwangmyeong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
InBody Co, Ltd.Cheonan-si Chungnam, South KoreaManufacturer0000api.fda.gov
Key-Tech Scotland LtdDunfermline Fife, United KingdomContract manufacturer0000api.fda.gov
Korea Body InformationSeoul, South KoreaManufacturer0000api.fda.gov
LPG SystemsVALENCE Drome, FranceSpecification developer0000api.fda.gov
Man & Company LimitedGumi-Si Gyeongbuk, South KoreaManufacturer0000api.fda.gov
MarsibionicsMADRID Madrid(Autonomous Community), SpainManufacturer0000api.fda.gov
Mcroberts BVthe hague Zuid-Holland, NetherlandsSpecification developer0000api.fda.gov
Medhab, LLCArlington, TX, United StatesManufacturer0000api.fda.gov
Medica Medizintechnik GMBHHOCHDORF Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Mirus, LLCMarietta, GA, United StatesManufacturer0000api.fda.gov
Modus Health, LLCMountlake Ter, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Movendo Technology SrlGenoa Genova, ItalyExporter to the US, Manufacturer0000api.fda.gov
P&S Robotics Co.,ltdSeoul, South KoreaManufacturer0000api.fda.gov
Perry Dynamics, Inc.Decatur, IL, United StatesManufacturer, Specification developer0000api.fda.gov
Roceso Technologies Pte. Ltd.Singapore, West South West, SingaporeManufacturer, Specification developer0000api.fda.gov
ROM Technologies, Inc.Brookfield, CT, United StatesManufacturer0000api.fda.gov
Shanghai Siyi Intelligent Technology Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Zdroid Medical Technology Co.,ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Smart Machines CorporationMedfield, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Startoon Labs Private LimitedHYDERABAD Telangana, IndiaManufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Shenzhen Shengye Technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sport Medical Technology IncShirley, NY, United StatesManufacturer0000api.fda.gov
Tyromotion GMBHGraz Steiermark, AustriaManufacturer0000api.fda.gov
Verve Precision Measurement IncArvada, CO, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Zhengzhou Angelexo Scientific Co., LtdZhengzhou Henan, ChinaManufacturer0000api.fda.gov
Zhuhai Rehaconn Medical Co., Ltd.Zhuhai Guangdong, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Zhejiang Mateside Medical Devices Technology Co., LtdNingbo Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated May 24, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.