Skip to the page

Data / Medical devices / Band Or Belt, Pelvic Support

Band Or Belt, Pelvic Support (ISR): 121 FDA-registered makers in 15 countries

121 establishments in 15 countries are registered with the FDA to make Band Or Belt, Pelvic Support (product code ISR, Class 1, 21 CFR 890.3025). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on February 8, 1979, 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
ISR
Device class
1
Regulation
890.3025
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China52
United States29
Taiwan15
India7
Mexico5
Canada3
Germany2
Dominican Republic1
Cambodia1
South Korea1
Vietnam1
Hong Kong1
France1
Egypt1
Latvia1

Makers of Band Or Belt, Pelvic Support

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
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Air A Med, LLCFort Myers, FL, United StatesSpecification developer0000api.fda.gov
Airway Surgical Appliances Ltd.NEPEAN Ontario, CanadaExporter to the US, Manufacturer0000api.fda.gov
Allmay Bodywear (shenzhen) Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Anji Huifeng Surgical Dressings Co., Ltd.ANJI COUNTY Zhejiang, ChinaContract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer0000api.fda.gov
Anping Guardian Medical Equipment Co.,ltdHengshui Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
AccuMed Corp.Nigua San Cristobal, Dominican RepublicContract manufacturer0000api.fda.gov
AlphapointeJamaica, NY, United StatesManufacturer0000api.fda.gov
Altimate Medical, Inc.Frankfort, IL, United StatesManufacturer0000api.fda.gov
BMS Great Lakes LLCKissimmee, FL, United StatesSpecification developer0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesContract manufacturer0000api.fda.gov
Brace AlignSoddy Daisy, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Braceability, Inc.Cedar Falls, IA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
BSN Medical S.A. de C.V.Reynosa Tamaulipas, MexicoManufacturer0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Beocare Inc., HudsonHudson, NC, United StatesManufacturer0000api.fda.gov
Comfy Health Group Co., Ltd.Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Concarey Medical Technology Co., LtdShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Docbrace (cambodia) Co., LtdPhnom Penh Capital, CambodiaContract manufacturer, Manufacturer0000api.fda.gov
Dong Guan Yunzhishang Health Technology Co.,ltd.Dongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Ness Sports Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Supercare Medical Products Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Du-Hope International GroupNANJING Jiangsu, ChinaManufacturer0000api.fda.gov
Dongguan China Effort Healthcare Products Co., Ltd.Dongguan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Electro Medical Equipment Co., Inc.Prairieville, LA, United StatesManufacturer0000api.fda.gov
Emsrun GroupWuxi Jiangsu, ChinaSpecification developer0000api.fda.gov
Fenghua Tealmed Emergency Products Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Fillauer, LLCChattanooga, TN, United StatesManufacturer0000api.fda.gov
Foshan Leawell Medical Technology Co.,ltdFOSHAN Guangdong, ChinaManufacturer0000api.fda.gov
FridaBaby LLCMiami, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Generalnet Co., Ltd.Gangnam-gu Seoul, South KoreaManufacturer0000api.fda.gov
Ghi Fu Technology Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Global TV Concepts, Ltd.Coconut Creek, FL, United StatesSpecification developer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Greatch Technology (Hebei) Co.,LtdHengshui City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangzhou Yifangjia Textile And Garment Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hameco Hy Co., LtdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Zhongzhi Industry Co.,ltdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hebei Youjie Medical Devices Co., LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaManufacturer0000api.fda.gov
Hengshui Runde Medical Instruments Co.,ltdHengshui City Hebei, ChinaManufacturer0000api.fda.gov
Hengshui Tianjian Medical Supplies Co., Ltd.ShenZhou City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hipsaver Inc.Canton, MA, United StatesManufacturer0000api.fda.gov
Huntex CorporationTaipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Hengshui Jingkang Medical Device Co.,Ltd.Hengshui City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
I-Ming Sanitary Materials Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Innovance Textiles LimitedHong Kong, Hong KongExporter to the US, Manufacturer0000api.fda.gov
Irufa Industrial Group Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Senolo Medical Technology Co., Ltd.Yancheng Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Senwo Medical Technology Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangxi Handasen Industry Co., LtdShangrao Jiangxi, ChinaManufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Juneng Sports Goods Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Kerma Medical Products, Inc.Suffolk, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
L&R Usa Inc.Milwaukee, WI, United StatesSpecification developer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Liven Sports MFG. (xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
M/S. Ascent Meditech LimitedGOREGAON (E) Maharashtra, IndiaManufacturer0000api.fda.gov
Magway Trading Inc.Markham Ontario, CanadaForeign private label distributor, Specification developer0000api.fda.gov
Majesty-Tech Product Development Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Maquiladora De Coahuila S De RL De CVCUIDAD ACUNA Coahuila, MexicoContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Medical Z, S.A.SAINT AVERTIN Indre-et-Loire, FranceManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtech Acuna S.A. De C.V.Acuna Coahuila, MexicoContract manufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ningbo MPF Manufacturing Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
NYOrthoBrooklyn, NY, United StatesManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyManufacturer, Specification developer0000api.fda.gov
Plus Meditech Co., Ltd. Plant 2Tainan City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Power Well Healthcare Technology Co., Ltd.Changhua County, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer0000api.fda.gov
Picard Healthcare Technology (Dongguan) Co. LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Richardson Products, Inc.Frankfort, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shenzhen Tohachi Industrial Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shijiazhuang Runyi Medical Device Technology Co.,ltd.Shijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Sia Tonus Elast / Tonus Elast LLC.Grinvalti,Nicas pag Nicas Novads, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Span Link International LLCDeer Park, NY, United StatesSpecification developer0000api.fda.gov
Special Protectors Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
STREIFENEDER ortho.production gmbHEMMERING Bavaria, GermanyExporter to the US, Manufacturer0000api.fda.gov
Suzhou Sunmed Co., LtdSUZHOU CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Serola Biomechanics, Inc.Loves Park, IL, United StatesManufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Shijiazhuang Aofeite Medical Device Co.,LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shock Doctor, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Ta Lai Sporting Goods Enterprises Co. Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
The Ergo Baby Carrier, Inc.Concord, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesManufacturer0000api.fda.gov
Top Longmax Products Co., Ltd.Taichung, TaiwanContract manufacturer0000api.fda.gov
Top Medical Corp.Chung Li City Taoyuan, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Trulife LimitedTRENTON Ontario, CanadaManufacturer0000api.fda.gov
Tuper Medical Co., Ltd.Dezhou City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Weihai Dishang Medical Technology Co.,ltdWeihai Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Welkong Sports Industrial Co.,ltdDongguan city Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Welltex Sports Co., Ltd.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Xiamen Huakang Orthopedic Co.,ltdXiamen City Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Yangzhou Aolikes Sports Goods Co., Ltd.Yangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yangzhou Jindu Sporting Goods Co., Ltd.Yangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yangzhou Juli Sports Articles Co.,ltd.YangZhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Qiangjing Sports Products Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Sensport Healthcare Supplies Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Luyao Electronics Technology Co.,ltdWenzhou Zhejiang, ChinaManufacturer0000api.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
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Steriger Sports Medicine Technology Co.,LtdYiwu Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated February 8, 1979. 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.