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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- IKK
- Device class
- 2
- Regulation
- 890.1925
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 19 |
| China | 9 |
| South Korea | 8 |
| United Kingdom | 4 |
| Singapore | 2 |
| Bulgaria | 1 |
| Israel | 1 |
| Hong Kong | 1 |
| France | 1 |
| Spain | 1 |
| Netherlands | 1 |
| Germany | 1 |
| Italy | 1 |
| India | 1 |
| Austria | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Activinsights Ltd. | Kimbolton Cambridgeshire, United Kingdom | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Articares Pte Ltd | SINGAPORE Central Singapore, Singapore | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assistive Technology Development, Inc. | Orange, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barrett Technology, LLC | Newton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bertec Corp. | Columbus, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioliberty Ltd | Edinburgh Edinburgh, City of, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biometrics Ltd. | Newport Wales, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioness Medical, Inc. | Valencia, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bte Technologies | Hanover, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BTL Industries JSC | Plovdiv, Bulgaria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioventus LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioxtreme Ltd. | Petach Tikva Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Jinuo Intelligent Technology Co., Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Computer Sports Medicine, Inc. | Stoughton, MA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cosmo Robotics Co., Ltd | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CUREXO, Inc. | Songpa-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Defond Electech Co., Ltd | Dongguan, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Figur8, Inc. | Boston, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fourier Intelligence Inc. | Shanghai, China | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Yikang Medical Equipment Industrial Co.,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H Robotics Inc. | Yeonsu-gu Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healing Innovations | Nashville, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hue Light Co., Ltd | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| InBody Co, Ltd. | Cheonan-si Chungnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key-Tech Scotland Ltd | Dunfermline Fife, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Korea Body Information | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LPG Systems | VALENCE Drome, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Man & Company Limited | Gumi-Si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marsibionics | MADRID Madrid(Autonomous Community), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcroberts BV | the hague Zuid-Holland, Netherlands | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medhab, LLC | Arlington, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Medizintechnik GMBH | HOCHDORF Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirus, LLC | Marietta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modus Health, LLC | Mountlake Ter, WA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Movendo Technology Srl | Genoa Genova, Italy | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P&S Robotics Co.,ltd | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perry Dynamics, Inc. | Decatur, IL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roceso Technologies Pte. Ltd. | Singapore, West South West, Singapore | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ROM Technologies, Inc. | Brookfield, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Siyi Intelligent Technology Co.,ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Zdroid Medical Technology Co.,ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smart Machines Corporation | Medfield, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Startoon Labs Private Limited | HYDERABAD Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Shengye Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sport Medical Technology Inc | Shirley, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tyromotion GMBH | Graz Steiermark, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Verve Precision Measurement Inc | Arvada, CO, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Angelexo Scientific Co., Ltd | Zhengzhou Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Rehaconn Medical Co., Ltd. | Zhuhai Guangdong, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mateside Medical Devices Technology Co., Ltd | Ningbo Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.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.