Data / Medical devices / Exerciser, Powered

Exerciser, Powered (BXB): 110 FDA-registered makers in 18 countries

Name: FDA-registered makers of Exerciser, Powered
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

110 establishments in 18 countries are registered with the FDA to make Exerciser, Powered (product code BXB, Class 1, 21 CFR 890.5380). 5 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 160 510(k) clearances under this code, the latest on January 25, 2008, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: BXB
Device class: 1
Regulation: 890.5380
Medical specialty: Physical Medicine

Makers by country

Country	Makers
United States	39
China	29
Germany	10
South Korea	7
Israel	3
France	3
Taiwan	3
Netherlands	3
United Kingdom	2
Italy	2
Guatemala	2
Japan	1
Poland	1
Vietnam	1
Norway	1
Hong Kong	1
Austria	1
Canada	1

Makers of Exerciser, Powered

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	Recall events	Source
Bte Technologies	Hanover, MD, United States	Manufacturer	1	January 21, 1980	0	api.fda.gov
Hill Laboratories	Frazer, PA, United States	Manufacturer	1	March 31, 1993	0	api.fda.gov
KLC Services, Inc./Reep	London, OH, United States	Manufacturer, Remanufacturer	1	October 5, 1995	0	api.fda.gov
Swimex Systems	Fall River, MA, United States	Manufacturer	1	January 9, 1995	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	1	January 21, 1983	0	api.fda.gov
Accelerated Care Plus Corp.	Reno, NV, United States	Repackager or relabeler, Specification developer	0		1	api.fda.gov
Active Optical Systems, Ltd./Efraim Bidas	PETACH-TIKVA Central, Israel	Manufacturer	0		0	api.fda.gov
Air A Med, LLC	Fort Myers, FL, United States	Specification developer	0		0	api.fda.gov
Allcare Innovations	Bourg-les-Valence Auvergne-Rhone-Alpes, France	Manufacturer	0		0	api.fda.gov
Aretech,llc	Sterling, VA, United States	Manufacturer	0		0	api.fda.gov
Anhui Kangfu Industrial Foreign Trade Co.,Ltd	Tianchang Anhui, China	Manufacturer	0		0	api.fda.gov
Biometrics Ltd.	Newport Wales, United Kingdom	Manufacturer	0		0	api.fda.gov
Bioness Medical, Inc.	Valencia, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Body Charger Fitness Int'l Corp(gee Hoo Fitec Corp)	Yuanlin City Changhua, Taiwan	Manufacturer	0		0	api.fda.gov
Bright Cloud International Corp.	Elkton, FL, United States	Manufacturer, Specification developer	0		0	api.fda.gov
BTT Health GMBH	Greifenberg Bavaria, Germany	Manufacturer, Specification developer	0		1	api.fda.gov
Bioventus LLC	Cordova, TN, United States	Contract manufacturer	0		0	api.fda.gov
Bojongmc Co.,Ltd	Siheung-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Chariot Innovations Inc	Woodway, TX, United States	Manufacturer	0		0	api.fda.gov
Cirtronics Corporation	Milford, NH, United States	Contract manufacturer	0		0	api.fda.gov
Cyberdyne Inc.	Tsukuba Ibaraki, Japan	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Care&Care Health Products Co., Ltd	Yuanli Township Miaoli, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
CranioMandibular Rehab, Inc.	Wheat Ridge, CO, United States	Specification developer	0		0	api.fda.gov
Daesung Maref Co.,ltd	Anyang-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Daesung Maref Co.,ltd	Gunpo-si Gyeonggi, South Korea	Manufacturer, Specification developer	0		0	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
DJO Global / Germany	Freiburg Baden-Wurttemberg, Germany	Exporter to the US, Manufacturer, Specification developer	0		0	api.fda.gov
Domino S.R.L.	Codogne Treviso, Italy	Manufacturer	0		0	api.fda.gov
Dpe Medical Ltd.	Beit Shemesh Jerusalem, Israel	Exporter to the US, Manufacturer	0		0	api.fda.gov
E. Bac Si Imports LLC	Ellensburg, WA, United States	Specification developer	0		0	api.fda.gov
Enraf-Nonius B.V.	ROTTERDAM Zuid-Holland, Netherlands	Manufacturer	0		0	api.fda.gov
ERGO FLEX Technologies LLC	Conroe, TX, United States	Manufacturer	0		0	api.fda.gov
FREE Bionics Taiwan Inc.	Hsinchu Hsinchu(City), Taiwan	Manufacturer	0		0	api.fda.gov
Full Range Rehab LLC	West Chester, OH, United States	Manufacturer	0		0	api.fda.gov
Fuzhou Feiwo Trading Co.,ltd	Fuzhou Fujian, China	Manufacturer	0		0	api.fda.gov
Fourier Intelligence Inc.	Shanghai, China	Manufacturer	0		0	api.fda.gov
GK Harmony Enterprises, Inc.	Houston, TX, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Good Medica Sp.zo.o.	Wroclaw Dolnoslaskie, Poland	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Guangdong Kareway Medical Technology Co., Ltd	Foshan Guangdong, China	Manufacturer	0		0	api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltd	Guangzhou Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Guangzhou Pinzhi Medical Technology Co., Ltd	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Guangzhou Longest Medical Technology Co., Ltd.	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Guatemala Medical Manufacturing	Villa Canales Guatemala, Guatemala	Contract manufacturer	0		0	api.fda.gov
H Robotics Inc.	Yeonsu-gu Incheon, South Korea	Manufacturer	0		0	api.fda.gov
H/P/Cosmos Sports & Medical GMBH	NUSSDORF BEI TRAUNSTEIN Bavaria, Germany	Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
H2O For Fitness LLC	Fort Wayne, IN, United States	Manufacturer	0		0	api.fda.gov
Halley Orthopedics	Southfield, MI, United States	Manufacturer	0		0	api.fda.gov
Hameco Hy Co., Ltd	Hung Yen Province, Vietnam	Manufacturer	0		0	api.fda.gov
Hangzhou Zhengda Medical Co.,ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Zhongzhi Industry Co.,ltd	Hangzhou Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Huangshan Jinfu Medical Equipment Co., Ltd.	Huangshan City Anhui, China	Manufacturer	0		0	api.fda.gov
Hurotics Inc.	Dongjak District Seoul, South Korea	Manufacturer	0		0	api.fda.gov
IPE Plastic & Hardware Industy, LTD	Dongguan Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Idrogenet S.R.L.	Lumezzane Brescia, Italy	Manufacturer	0		0	api.fda.gov
Jiangsu Rooe Medical Technology Co., Ltd.	Zhangjiagang City Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
JK Products GMBH	BAD HONNEF North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Johnson Health Tech (shanghai) Co., Ltd.	Jiading Shanghai, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Kaiser Medical Inc	West Grove, PA, United States	Manufacturer	0		0	api.fda.gov
KBL GmbH	Dernbach Rhineland-Palatinate, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Kinetec Usa	Jackson, WI, United States	Specification developer	0		0	api.fda.gov
Kinex Medical Company	Waukesha, WI, United States	Manufacturer	0		0	api.fda.gov
Kinetec SAS	Tournes Ardennes, France	Manufacturer	0		0	api.fda.gov
Lite Run Inc	Saint Paul, MN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
LPG Systems	VALENCE Drome, France	Manufacturer, Specification developer	0		0	api.fda.gov
Lifeward LTD.	Upper Yokneam Northern, Israel	Manufacturer, Remanufacturer	0		0	api.fda.gov
M20 Co.,ltd.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Made For Movement Group AS	Skien Telemark, Norway	Exporter to the US, Manufacturer	0		0	api.fda.gov
Man & Company Limited	Gumi-Si Gyeongbuk, South Korea	Manufacturer	0		0	api.fda.gov
Medica Medizintechnik GMBH	HOCHDORF Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
MEDIREHA GmbH	Umkirch Baden-Wurttemberg, Germany	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Medirobotic Technology Co., Ltd.	Qingdao Shandong, China	Manufacturer	0		0	api.fda.gov
Motek Medical B.V.	Houten Noord-Brabant, Netherlands	Complaint file establishment, Manufacturer, Specification developer	0		1	api.fda.gov
Motus Nova	Atlanta, GA, United States	Manufacturer	0		0	api.fda.gov
Nextstep Robotics Inc.	Baltimore, MD, United States	Complaint file establishment, Manufacturer, Remanufacturer	0		0	api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.	Ningbo, Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Novotec Medical GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
One Direct Health	Marietta, GA, United States	Manufacturer	0		0	api.fda.gov
Ortho and Surgical Products Enterprises S.A.	Villa Canales Guatemala, Guatemala	Contract manufacturer	0		0	api.fda.gov
Performance Health Systems, LLC	Northbrook, IL, United States	Manufacturer	0		0	api.fda.gov
R & D Batteries, Inc.	Burnsville, MN, United States	Manufacturer	0		0	api.fda.gov
Reck-Technik GMBH & Co. KG	BETZENWEILER Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
REGENERATIVE TECHNOLOGIES CORP dba JUVENT	Ooltewah, TN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Reha-Stim Medtec GMBH	Berlin, Germany	Manufacturer	0		0	api.fda.gov
Rehab-Robotics Company Limited	Hong Kong, Hong Kong	Manufacturer	0		0	api.fda.gov
Rehabtek LLC	Linthicum Heights, MD, United States	Manufacturer	0		0	api.fda.gov
Restorative Therapies Inc.	Nottingham, MD, United States	Manufacturer	0		0	api.fda.gov
Shanghai Sirrem Medical Devices Co.,ltd	Shanghai, China	Manufacturer	0		0	api.fda.gov
Shanghai Siyi Intelligent Technology Co.,ltd.	Shanghai, China	Manufacturer	0		0	api.fda.gov
Shanghai Zdroid Medical Technology Co.,ltd.	Shanghai, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Eyco Technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Youmay Electronics Co., Ltd	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Sport Medical Technology Inc	Shirley, NY, United States	Manufacturer	0		0	api.fda.gov
Tianjin Goldenall Medical Device Co.,ltd	Tianjin city, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Titin KM Biomedical Corp.	Bozeman, MT, United States	Complaint file establishment, Manufacturer, Remanufacturer	0		0	api.fda.gov
Tyromotion GMBH	Graz Steiermark, Austria	Manufacturer	0		0	api.fda.gov
Tecogics Scientific Ltd	Ottawa Ontario, Canada	Manufacturer, Specification developer	0		0	api.fda.gov
The Furniss Corporation Ltd	Mount Sterling, OH, United States	Manufacturer	0		0	api.fda.gov
Theraplay Ltd	East Kilbride South Lanarkshire, United Kingdom	Manufacturer	0		0	api.fda.gov
Ultrasun	HENGELO Overijssel, Netherlands	Manufacturer	0		0	api.fda.gov
Vibetech Enterprises, LLC	Sheboygan, WI, United States	Manufacturer	0		0	api.fda.gov
Xeras Medical Technologies	San Antonio, TX, United States	Specification developer	0		0	api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.	Xiamen Fujian, China	Manufacturer	0		0	api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.	Xiamen Free Trade Zone Fujian, China	Manufacturer	0		0	api.fda.gov
Xiamen Weiyou Intelligent Technology Co.,Ltd	xiamen Fujian, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Zhangzhou Liyuan Sporting Goods Co Ltd	Zhangzhou Fujian, China	Manufacturer	0		0	api.fda.gov
Zhejiang Longyou Landmedical Technology Co.,ltd.	longyou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Todo Hardware Manufacture Co.,ltd	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zhengzhou Angelexo Scientific Co., Ltd	Zhengzhou Henan, China	Manufacturer	0		0	api.fda.gov
Zhejiang Mateside Medical Devices Technology Co., Ltd	Ningbo Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Zona Health, Inc.	Montgomery, AL, United States	Complaint file establishment, Manufacturer, Manufacturer for export	0		0	api.fda.gov

Updated January 25, 2008. 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.