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Data / Medical devices / Cover, Mattress (Medical Purposes)

Cover, Mattress (Medical Purposes) (FMW): 175 FDA-registered makers in 25 countries

175 establishments in 25 countries are registered with the FDA to make Cover, Mattress (Medical Purposes) (product code FMW, Class 1, 21 CFR 880.6190). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on June 20, 2016, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FMW
Device class
1
Regulation
880.6190
Medical specialty
General Hospital

Makers by country

CountryMakers
China77
United States48
Canada8
Taiwan7
Malaysia4
Mexico4
Vietnam3
South Korea3
Turkey2
India2
El Salvador2
Pakistan2
Japan1
Chile1
Sweden1
Netherlands1
United Kingdom1
Estonia1
Spain1
Bangladesh1
Cambodia1
Switzerland1
Philippines1
Colombia1
Germany1

Makers of Cover, Mattress (Medical Purposes)

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
Precision Fabrics Group, Inc.Greensboro, NC, United StatesManufacturer1January 25, 2007000api.fda.gov
2712218 Ontario IncConcord Ontario, CanadaManufacturer0000api.fda.gov
5 Minds MobilityOshawa Ontario, CanadaManufacturer0000api.fda.gov
Alimed, LLCDedham, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Alpha TeknikoLake Zurich, IL, United StatesManufacturer0000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Anhui Ares Medical Technology Co.,ltd.Tianchang Anhui, ChinaManufacturer0000api.fda.gov
Anhui JM Healthcare Products Co.,ltd.Shouxian Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anqing Kangmingna Packaging Co.,ltdAnqing Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ari Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Atom Medical CorporationSakura-ku, Saitama-shi, JapanManufacturer0000api.fda.gov
Agiliti Health - CoronaCorona, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Beck's ClassicBrentwood, NY, United StatesContract manufacturer0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Care Line, Inc.Greenbrier, TN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Casco Manufacturing Solutions, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Changshu Welland Textiles Co.,ltdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Care-De Sanitary Material Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Hongtai Paper Film Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Newrise Medical & Hygiene Products Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Confitex Apparel Technology Co. Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Cognito Health Inc.Taipei, TaiwanManufacturer0000api.fda.gov
Dalian Rongbang Medical Healthy Devices Co LtdDalian Liaoning, ChinaManufacturer0000api.fda.gov
Derby IndustriesSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Dongguan Mingfu Industry Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Domico Med-Device, LLCFenton, MI, United StatesManufacturer0000api.fda.gov
Dongguan China Effort Healthcare Products Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Essity Canada Inc.DRUMMONDVILLE Quebec, CanadaManufacturer0000api.fda.gov
Essity HMS North America Inc.Bowling Green, KY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Essity Hygiene and Health ABGothenburg Vastra Gotaland, SwedenManufacturer, Specification developer0000api.fda.gov
Essity Operations Gennep B.V.GENNEP Limburg, NetherlandsManufacturer0000api.fda.gov
Frontier Therapeutics LimitedTredegar Blaenau Gwent, United KingdomComplaint file establishment, Specification developer0000api.fda.gov
Fujian Quanzhoucity Aile Hygiene Products Co.,ltd.Nanan City Fujian, ChinaManufacturer0000api.fda.gov
Fujian Time And Tianhe Industrial Co., LtdNanan Fujian, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Future Foam IncE Providence, RI, United StatesContract manufacturer0000api.fda.gov
Gentug Tekstil Urunleri A.S.Istanbul, TurkeyManufacturer0000api.fda.gov
George Courey IncMontreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
GF Health Products, IncAtlanta, GA, United StatesManufacturer0000api.fda.gov
GLX Medical Devices Company LimitedBien Hoa Dong Nai, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Greatcare 4u Sdn BhdSelangor Darul Ehsan, MalaysiaManufacturer0000api.fda.gov
Green Energy Nano Technology Co., LtdNew Taipei City, TaiwanManufacturer0000api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.JIAXING Zhejiang, ChinaManufacturer0000api.fda.gov
Guangdong Junfeng BFS Technology Co., Ltd.guangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangdong Yazhi Technology Co., LtdHuizhou City Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong Yuehua Medical Instrument Factory Co., Ltd.Shantou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guangzhou Baoli Hardware & Electronic Co.,ltd.Guangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Gabriel Scientific OUParnu linn Parnumaa, EstoniaManufacturer0000api.fda.gov
Greenwood Marketing LLC - IndyPlainfield, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Haining Hengshang Knitting Co., LtdJIAXING Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Haining Meike Textile Co.,ltd.Haining Zhejiang, ChinaManufacturer0000api.fda.gov
Haining Yikang Textile Co., LtdHaining Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Alline Plastic Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou Musen Import And Export Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hebei Webian Medical Instrument Trading Co., LtdSHIJIAZHUANG CITY Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hefei MT Medical Co.,ltd.Hefei Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Henan Joinkona Medical Products Stock Co.,ltdPingdingshan Henan, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
Hi-Life Technology (hebei) Co.,ltd.Bazhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hong Ming Enterprise Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Honghu Danielle Sanitary Material Co., Ltd.Honghu City Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hot & Hot Co., Ltd.Namyangju-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Heye Health Technology Co., Ltd.HuZhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hubei Haixin Protective Products Group Co.,LtdSongzi City Hubei, ChinaContract manufacturer0000api.fda.gov
ICARE MEDICAL GROUP USA, IncGothenburg, NE, United StatesManufacturer0000api.fda.gov
Icat S.A. De C.V.San Salvador, El SalvadorContract manufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoComplaint file establishment, Contract manufacturer0000api.fda.gov
Improving Mobility Development SLLLIRIA Valencia(Province), SpainSpecification developer0000api.fda.gov
Integrated Medcraft LLCEast Hampton, CT, United StatesSpecification developer0000api.fda.gov
International Textile LimitedKarachi Sindh, PakistanContract manufacturer0000api.fda.gov
Immersus Health Company, LLCMilford, OH, United StatesSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
J. Lynch Co., Ltd.Kaohsiung, TaiwanContract manufacturer0000api.fda.gov
Jac Custom PouchesDowagiac, MI, United StatesContract manufacturer0000api.fda.gov
JHQ New Material Technology Co., Ltd.Wuxi Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Hanfang Textile Technology Co., LtdXuzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiangsu Keling Medical Appliances Co.,ltd.Yangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Rooe Medical Technology Co., Ltd.Zhangjiagang City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Saikang Medical Equipment Co., LtdZhangjiagang Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Yongfa Medical Equipment Technology Co., LtdZhangjiagang City Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangyin Unixcare Medical Devices Co.,ltdJiangyin Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiaxing Weimei Textile Co., LtdJiaxing City Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiehong Medical Products(bangladesh) Co.ltdChattogram Chittagong(Division), BangladeshContract manufacturer, Manufacturer0000api.fda.gov
Jingxin Group (M) Sdn BhdKulai Johor, MalaysiaManufacturer0000api.fda.gov
Jingxin Group (M) Sdn BhdKulai Johor, MalaysiaManufacturer0000api.fda.gov
Jinhua Yueer Art Craft Co.,ltdJinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Jiangyin Huashi Medical Equipment Co.,LtdJiangyin City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jinhua Ivy Home Textile Co. Limited.Jinhua City Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Joerns HealthcareCharlotte, NC, United StatesSpecification developer0000api.fda.gov
Joerns HealthcareArlington, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Joerns Healthcare BrownsvilleBrownsville, TX, United StatesManufacturer0000api.fda.gov
K2 Health ProductsBrooklyn, NY, United StatesSpecification developer0000api.fda.gov
Kap MedicalCorona, CA, United StatesManufacturer0000api.fda.gov
Kentron Health Care, Inc.Springfield, TN, United StatesManufacturer, Specification developer0000api.fda.gov
Khing Good CompanyDONG GUAN Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kimlead Hygiene Products (hebei) Co.,ltd.Xingtai Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kreg Medical, Inc.Melrose Park, IL, United StatesManufacturer0000api.fda.gov
Kuangzan (Zhejiang) Home Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Lingxian Dongsheng Textile Co., Ltd.Dezhou Shandong, ChinaManufacturer0000api.fda.gov
Linjiang (holdings) LimitedShangqiu Henan, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
LKL Advance Metaltech Sdn BhdSeri Kembangan Selangor, MalaysiaManufacturer0000api.fda.gov
Lucky Textile Mills LimitedKARACHI Sindh, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim SirketiIzmir, TurkeyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtecs (cambodia) Corp. LimitedSrok Kampong Siem Kampong Cham, CambodiaContract manufacturer, Foreign private label distributor0000api.fda.gov
MesSeguin, TX, United StatesSpecification developer0000api.fda.gov
Mip UsaBolingbrook, IL, United StatesSpecification developer0000api.fda.gov
Mip, Inc.ANJOU Quebec, CanadaSpecification developer0000api.fda.gov
Moxi Enterprises, LLCGreenville, SC, United StatesManufacturer, Specification developer0000api.fda.gov
Medtrica Solutions LtdSurrey British Columbia, CanadaContract manufacturer, Manufacturer0000api.fda.gov
Mildy International Branch CompanyCan Tho City, VietnamManufacturer0000api.fda.gov
Ningbo Jiaqi Apparel Co., LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
North America Mattress Corp.Clackamas, OR, United StatesManufacturer0000api.fda.gov
Pearl Technology AGSchlieren Zurich, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov
Philipcare Medical Manufacturing Inc.Lipa Batangas, PhilippinesContract manufacturer, Manufacturer0000api.fda.gov
Poliuretanos, S.A. De C.V.Toluca Mexico, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Pottymd, LLCKnoxville, TN, United StatesSpecification developer0000api.fda.gov
Protect-A-Bed Korea Co., Ltd.Seongnam Gyeonggi, South KoreaSpecification developer0000api.fda.gov
Protection Products, Inc.Hickory, NC, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Paras Surgico FactoryDelhi, IndiaManufacturer0000api.fda.gov
Picard Healthcare Technology (Dongguan) Co. LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Quanzhou Apex Hygiene Products Co.,ltdJinjiang Fujian, ChinaManufacturer0000api.fda.gov
Radscan Medical Equipment, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Rogers Foam CorporationMt Sterling, KY, United StatesContract manufacturer0000api.fda.gov
ROHO, Inc.Belleville, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ronexmed S.A.S.Barranquilla Atlantico, ColombiaContract manufacturer0000api.fda.gov
Rugao Smiling Healthcare Teconolgy Developent Co., LtdRugao Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Rogers Foam Tijuana S. de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Secure Personal Care Products, LLCSouth San Francisco, CA, United StatesSpecification developer0000api.fda.gov
Shandong Aishule Hygiene Products Co., LtdLinyi Shandong, ChinaManufacturer0000api.fda.gov
Shandong Kangli Medical Equipment Technology Co., Ltd.Zaozhuang Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai No. 2 Medical College Duhang Medical Equipment FactoryShanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shanghai Shenbao Mattress FactoryShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Yueyueshu Women Products Co.,ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenyang Ourpromise Medical Equipment Co., Ltd.Shenyang Liaoning, ChinaExporter to the US, Manufacturer0000api.fda.gov
Span-America Medical Systems, Inc.Greenville, SC, United StatesManufacturer0000api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Stryker MedicalPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sun May Industrial Co., Ltd.Pan Chiao City Taipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Surface Medical, Inc.Calgary Alberta, CanadaSpecification developer0000api.fda.gov
Suzhou Baili Medical Supplies Co.,ltdSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Shenzhen Lantise Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Sichuan AST Medical Equipment Co., LtdLuzhou City Sichuan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Sloan MedicalOmaha, NE, United StatesManufacturer, Specification developer0000api.fda.gov
Small Beginnings Inc.Hesperia, CA, United StatesManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Tamarack Habilitation Technologies, Inc.Blaine, MN, United StatesManufacturer0000api.fda.gov
Taylor Healthcare Products, IncSpring, TX, United StatesSpecification developer0000api.fda.gov
The Pettibon SystemChehalis, WA, United StatesManufacturer0000api.fda.gov
Trinity Furniture Co., Ltd.Seongnam-si Gyeonggi, South KoreaSpecification developer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Vidales Larranaga SA de CVAhuachapan, El SalvadorContract manufacturer0000api.fda.gov
WCW,IncManchester Center, VT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Weifang Keepbetter Healthcare Co., Ltd.Weifang Shandong, ChinaManufacturer0000api.fda.gov
Welkong Sports Industrial Co.,ltdDongguan city Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wuhan Youfu International Trade Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wuhu Qicheng New Material Co.,ltd.Wuhu Anhui, ChinaContract manufacturer0000api.fda.gov
Wuyi Kinda Industry & Trade Co., LtdJINHUA Zhejiang, ChinaManufacturer0000api.fda.gov
Walt Technology Group Co., Ltd.Haining Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Walt USA, LLCLogan, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,LtdWeihai Shandong, ChinaManufacturer0000api.fda.gov
Xian Tao Crosscare Protective Products Co.,ltdXian Tao Hubei, ChinaManufacturer0000api.fda.gov
Yong Yi Viet Nam Co.,ltdDuc Hoa Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Zhangjiagang Carenovo Technology Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Zhejiang Shininglion Technology Co.,ltdHuzhou City Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Tianyue Import And Export Co., Ltd.Haining Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Saxin Electric Heating Technology Co., Ltd.Zhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Zhejiang Longterm Medical Technology Co., LTDHuzhou City Zhejiang, ChinaManufacturer0000api.fda.gov

Updated June 20, 2016. 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.