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Data / Medical devices / Components, Exercise

Components, Exercise (IOD): 91 FDA-registered makers in 14 countries

91 establishments in 14 countries are registered with the FDA to make Components, Exercise (product code IOD, Class 1, 21 CFR 890.5350). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on June 24, 1983, and lists 0 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
IOD
Device class
1
Regulation
890.5350
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States39
China29
Vietnam5
Mexico4
Taiwan3
Malaysia2
Hong Kong2
Pakistan1
India1
Netherlands1
Brazil1
Sri Lanka1
South Korea1
Thailand1

Makers of Components, Exercise

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
Alimed, LLCDedham, MA, United StatesManufacturer, Specification developer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesSpecification developer0000api.fda.gov
Aspire Products, LLCSwansboro, NC, United StatesManufacturer0000api.fda.gov
Altimate Medical, Inc.Frankfort, IL, United StatesManufacturer0000api.fda.gov
Ashley Black Inc.Houston, TX, United StatesSpecification developer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Boost Therapeutic Innovations, LLCGainesville, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Boyang Sporting Goods Co., LtdHo Chi Minh City Binh Duong, VietnamContract manufacturer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (3)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (4)Mexicali Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
Changzhou Yaohong Metric Manufacturing Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Chuan Yi Qi Tech Shen Zhen Co., LtdShen Zhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Cixi Yongye Furniture Co.,ltdCixi Zhejiang, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Core Products Intl., Inc.Osceola, WI, United StatesManufacturer0000api.fda.gov
Clinton Industries, IncYork, PA, United StatesManufacturer0000api.fda.gov
Danyang New Hope Medical Equipment Co., LtdDanyang Jiangsu, ChinaManufacturer0000api.fda.gov
DepcoHauppauge, NY, United StatesManufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dong Guan Yunzhishang Health Technology Co.,ltd.Dongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan City Fenglinwan Leisure Products Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Dongguan Redthera Technology Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
E. Bac Si Imports LLCEllensburg, WA, United StatesSpecification developer0000api.fda.gov
Elastomerix Vietnam Co. LtdHo Chi Minh City Binh Duong, VietnamContract manufacturer0000api.fda.gov
Fabrication Ent., Inc.Elmsford, NY, United StatesManufacturer0000api.fda.gov
Fit For Life, LLCEmpire State, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Foshan Huafukang Medical Technology Co. LtdFoshan City Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Foshan Zubon Technology Co.,ltd.Foshan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Fengtai County Guqiao Town Changxing Shoe FactoryHuainan City Anhui, ChinaContract manufacturer0000api.fda.gov
Flint Rehabilitation Devices, LLCIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Guangmei VN Production Service Trade Company LimitedThuan An Binh Duong, VietnamContract manufacturer0000api.fda.gov
Guangdong Hexin Technology Weaving Co., LTDHuizhou City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hameco Hy Co., LtdHung Yen Province, VietnamManufacturer0000api.fda.gov
Hangzhou Zhongzhi Industry Co.,ltdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Harvard MedtechLas Vegas, NV, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Health Plus (shanghai) International Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hochuen Medical Sdn. Bhd.SENAI Johor, MalaysiaContract manufacturer0000api.fda.gov
Hong Kong Lute Technology Co., LimitedHong Kong, Hong KongForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Hochuen Medical Technology Co.,Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Implus Footcare LLCDurham, NC, United StatesSpecification developer0000api.fda.gov
Indica-Mcs LLCFowlerville, MI, United StatesContract manufacturer0000api.fda.gov
Jasan International LimitedHong Kong, Hong KongExporter to the US, Manufacturer0000api.fda.gov
Jiangyin Mingyan Plastic Products Co., LtdJiangyin Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiarui Invest Industry Co., Ltd.Hsien Changhua, TaiwanManufacturer0000api.fda.gov
Jinhua Beili Knitting Co.,ltd.JINHUA Zhejiang, ChinaManufacturer0000api.fda.gov
Konliking Tech & Dev. LimitedShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Kunshan Hi-Fortune Health Products Co., Ltd.Kunshan City, Jiangsu, ChinaManufacturer0000api.fda.gov
MASS Rehab Inc.Moraine, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Motek Medical B.V.Houten Noord-Brabant, NetherlandsSpecification developer0000api.fda.gov
Ningbo Landing Technology Company Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo MPF Manufacturing Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
New Century Products Co. LtdTaipei City, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Optp LLCMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
Orthomed, LLCWhittier, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Otto Bock (china) Industries Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Ortho Pauher Ind. Com. E Dist. LtdaRecife Pernambuco, BrazilExporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
P.C.P. ChampionRipley, OH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Personal Medical Corp.Bothell, WA, United StatesManufacturer0000api.fda.gov
Plasticity NeurorehabilitationEvansville, IN, United StatesSpecification developer0000api.fda.gov
Professional Specialties Co., Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
PTWorks, LLCPleasant Grove, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Position Health, LLCLake Forest, IL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Quality Latex Products (pvt) Ltdhanwella Western, Sri LankaManufacturer0000api.fda.gov
Qidong Yongsheng Medical Products FactoryQidong City Jiangsu, ChinaManufacturer0000api.fda.gov
Richardson Products, Inc.Frankfort, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Saehan CorporationChangwon Gyeongnam, South KoreaManufacturer0000api.fda.gov
Sanctuary Health Sdn BhdChemor Perak, MalaysiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Obestec Industrial Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Root Innovation Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Zhouyang Medical Care Product Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Skil-Care Corp.New Rochelle, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Suzhou Pipi Medical Products Co.,ltdSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
The Hygenic Company, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
The Pettibon SystemChehalis, WA, United StatesManufacturer0000api.fda.gov
Theradapt Products Inc.Ludington, MI, United StatesManufacturer0000api.fda.gov
Therapeutic Dimensions Inc.Spokane, WA, United StatesSpecification developer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesManufacturer0000api.fda.gov
Tie Xin Industrial Co., Ltd.Hsien Changhua, TaiwanManufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Union Pioneer Public Co., LtdBangkok Krung Thep Maha Nakhon, ThailandContract manufacturer0000api.fda.gov
Xiamen Sunnyway Plastic Co., Ltd.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.Zhongshan City, Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zeffer Research & Assoc. S. A. de C. V.Ensenada Baja California, MexicoContract manufacturer, Manufacturer0000api.fda.gov

Updated June 24, 1983. 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.