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Data / Medical devices / Dynamometer, Nonpowered

Dynamometer, Nonpowered (HRW): 40 FDA-registered makers in 13 countries

40 establishments in 13 countries are registered with the FDA to make Dynamometer, Nonpowered (product code HRW, Class 1, 21 CFR 888.1250). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on April 20, 1998, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code
HRW
Device class
1
Regulation
888.1250
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States13
Germany6
India3
Taiwan3
China3
Mexico3
Malaysia3
Pakistan1
France1
Italy1
Israel1
Sweden1
South Korea1

Makers of Dynamometer, Nonpowered

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
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
AutomatedassessmentsOmaha, NE, United StatesManufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
Charder Electronic Co., LtdTaichung City, TaiwanManufacturer0000api.fda.gov
Chartek Electronic (Yang Zhou) LtdYangzhou City, Jiansu Province Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Fabrication Ent., Inc.Elmsford, NY, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guangzhou Goldsun Electronic Co. LtdGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Handexer LLCSouth El Monte, CA, United StatesManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
JetyoChanghua, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
JTECH Medical Industries, Inc.Midvale, UT, United StatesManufacturer0000api.fda.gov
Kinvent BiomecaniqueMontepellier Herault, FranceManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Lafayette Instrument Co., Inc.La Fayette, IN, United StatesManufacturer0000api.fda.gov
Limacorporate S.p.A.Villanova di San Daniele Udine, ItalyManufacturer0000api.fda.gov
Medoc Ltd.RAMAT YISHAI Northern, IsraelManufacturer0000api.fda.gov
Meloq ABStockholm, SwedenComplaint file establishment, Manufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Performance Health Supply, LLC.Cedarburg, WI, United StatesSpecification developer0000api.fda.gov
Rudolf Riester GMBHJUNGINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Saehan CorporationChangwon Gyeongnam, South KoreaManufacturer0000api.fda.gov
Seacomp DisplaysTijuana Baja California, MexicoContract manufacturer0000api.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
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
The Hygenic Company, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
W+S Solutions GMBHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov

Updated April 20, 1998. 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.