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Data / Medical devices / Halter, Head, Traction

Halter, Head, Traction (HSS): 42 FDA-registered makers in 11 countries

42 establishments in 11 countries are registered with the FDA to make Halter, Head, Traction (product code HSS, Class 1, 21 CFR 888.5890). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on June 27, 1977, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HSS
Device class
1
Regulation
888.5890
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States10
China9
India7
Taiwan4
Germany3
Malaysia3
Guatemala2
Dominican Republic1
Vietnam1
Mexico1
Pakistan1

Makers of Halter, Head, Traction

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
A & I Industries LtdFOSHAN CITY Guangdong, ChinaManufacturer0000api.fda.gov
Alimed, LLCDedham, MA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
Changzhou Well Lands Technology Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Dragon Medical Co.,LtdSuzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Headstar Medical Products Co., LtdNew Taipei City, TaiwanManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Huntex CorporationTaipei, TaiwanManufacturer0000api.fda.gov
Intelivation Technologies, LLCPlymouth Meeting, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract 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
Kinetec UsaJackson, WI, United StatesSpecification developer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Medical Materials And Equipment Manufacturing, Well Lands Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mizuho Orthopedic Systems, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
P.C.P. ChampionRipley, OH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer0000api.fda.gov
Shanghai No. 2 Medical College Duhang Medical Equipment FactoryShanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenyang Ourpromise Medical Equipment Co., Ltd.Shenyang Liaoning, ChinaExporter to the US, Manufacturer0000api.fda.gov
Staan Biomed Engineering Private LimitedCOIMBATORE Tamil Nadu, IndiaManufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Surgical Appliance Industries, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zhongshan A&e Machinery Industry Co., LtdZhongshan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated June 27, 1977. 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.