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Data / Medical devices / Joint, Ankle, External Brace / United States

FDA-registered makers of Joint, Ankle, External Brace in the United States: 98 establishments

98 establishments in the United States are registered with the FDA to make Joint, Ankle, External Brace (product code ITW). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Joint, Ankle, External Brace
Product code
ITW
Country
United States

Makers of Joint, Ankle, External Brace in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Air A Med, LLCFort Myers, FL, United StatesSpecification developer0000api.fda.gov
Alex Orthopedic, Inc.Grand Prairie, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Amitofo Inc.Denver, CO, United StatesManufacturer0000api.fda.gov
Anatomical Concepts, Inc.Poland, OH, United StatesManufacturer0000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Aspen Medical Products, LLCIrvine, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Action PackagingWoodstock, IL, United StatesSpecification developer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
Becker Orthopedic Appliance Co.Troy, MI, United StatesManufacturer0000api.fda.gov
Benik Corp.Silverdale, WA, United StatesManufacturer0000api.fda.gov
Biosculptor CorporationHialeah, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bossong Hosiery MillsAsheboro, NC, United StatesManufacturer0000api.fda.gov
Boston Brace International, IncorporatedStoughton, MA, United StatesComplaint file establishment, 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
Breg, Inc.Carlsbad, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bauerfeind USA, INC.Atlanta, GA, United StatesSpecification developer0000api.fda.gov
BioSkin LLCAshland, OR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
BrownmedSpirit Lake, IA, United StatesManufacturer0000api.fda.gov
Comforback IncAuburndale, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Comfortland International, LLCMebane, NC, United StatesSpecification developer0000api.fda.gov
Core Products Intl., Inc.Osceola, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Core Products International IncChetek, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Darco International, Inc.Huntington, WV, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Doctor In The HouseBlue Bell, PA, United StatesManufacturer0000api.fda.gov
Dynasplint Systems, Inc.Stevensville, MD, United StatesManufacturer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Elite Orthopaedics, Inc.South El Monte, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Ergoactives, LLCMiami, FL, United StatesSpecification developer0000api.fda.gov
Fillauer, LLCChattanooga, TN, United StatesManufacturer0000api.fda.gov
Fit For Life, LLCEmpire State, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Global TV Concepts, Ltd.Coconut Creek, FL, United StatesSpecification developer0000api.fda.gov
Greenwood Marketing LLCBrandenburg, KY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Hely & WeberDfw, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Icarus Medical LLCCharlottesville, VA, United StatesManufacturer0000api.fda.gov
Ideavillage Products Corp.Wayne, NJ, United StatesSpecification developer0000api.fda.gov
Incrediwear Holdings, Inc.Chico, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Ing Source, Inc.Hickory, NC, United StatesComplaint file establishment, Repackager or relabeler, Reprocessor, Specification developer0000api.fda.gov
Innomotive LLCEast Lansing, MI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Kenad SG Medical, Inc.Bartlett, TN, 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
Lenjoy Medical Engineering, Inc.Gardena, CA, United StatesManufacturer0000api.fda.gov
Life Wear Technologies, Inc.Pompano Beach, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Manamed LLCDenton, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medical Specialties, Inc.Wadesboro, NC, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mobility Braces, LLCNorth Salt Lake, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Nolaro24 LLCMiddlebury, CT, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Ontel Products CorporationFairfield, NJ, United StatesSpecification developer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Otto Bock Healthcare LPSalt Lake City, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pro-Tech InternationalRaynham, MA, United StatesManufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Protect3d, Inc.Durham, NC, United StatesManufacturer0000api.fda.gov
Proteor UsaTempe, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
PROTEOR USA, GunnisonGunnison, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Precision Medical ProductsRocklin, CA, United StatesSpecification developer0000api.fda.gov
Remington Products Company LLCWadsworth, OH, United StatesSpecification developer0000api.fda.gov
Restorative Care Of America, Inc.Saint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Richardson Products, Inc.Frankfort, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Reflex GroupOceanside, CA, United StatesSpecification developer0000api.fda.gov
Samgen Medical LLCCherry Hill, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Secured Ortho Manufacturing Of America, LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Sleeve Stars LLCEstero, FL, United StatesSpecification developer0000api.fda.gov
Span Link International LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
ST&G Usa Corporation / ChoiBrea, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Shock Doctor, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Tamarack Habilitation Technologies, Inc.Blaine, MN, United StatesManufacturer0000api.fda.gov
Tayco Brace, IncSouth Bend, IN, United StatesSpecification developer0000api.fda.gov
Tesla Biohealing, Inc.Milford, DE, United StatesContract manufacturer, Manufacturer0000api.fda.gov
The Hygenic Company, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
Thorwear Inc. Dba Elevate MovementCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Trend Medical, LLCBethlehem, PA, United StatesSpecification developer0000api.fda.gov
Trulife, Inc.Bellingham, WA, United StatesManufacturer, Specification developer0000api.fda.gov
Thuasne, LLCBakersfield, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
U.S. Orthotics, Inc.Tampa, FL, United StatesManufacturer0000api.fda.gov
Ulcer Solutions, LLCRidgefield, WA, United StatesSpecification developer0000api.fda.gov
Unite Medical, LLCLithia Springs, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
United Surgical LLCLaotto, IN, United StatesRepackager or relabeler, Specification developer0010api.fda.gov
VIVE Health LLCNaples, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Wilsons nc Enterprice LLCWashington, NC, United StatesSpecification developer0000api.fda.gov
Xo Armor Technologies IncAuburn, AL, United StatesManufacturer, Specification developer0000api.fda.gov
pfs med, incSpringfield, OR, United StatesManufacturer, Remanufacturer0000api.fda.gov

Updated November 2, 2026. 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.