Data / Medical devices / Orthosis, Limb Brace / United States
FDA-registered makers of Orthosis, Limb Brace in the United States: 147 establishments
147 establishments in the United States are registered with the FDA to make Orthosis, Limb Brace (product code IQI). 0 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 3, 2026.
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- Device
- Orthosis, Limb Brace
- Product code
- IQI
- Country
- United States
Makers of Orthosis, Limb Brace in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3M Company | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Alignmed Inc. | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alimed, LLC | Dedham, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpha Medical L.L.C. | Rock Hill, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anodyne | Milwaukee, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Medical Products, LLC | Irvine, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barbaras Development, Inc. | Thousand Oaks, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becker Orthopedic Appliance Co. | Troy, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biosculptor Corporation | Hialeah, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bird & Cronin, LLC | Eagan, MN, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bone Foam Inc. | Minneapolis, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Brace International, Incorporated | Stoughton, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brace Align | Soddy Daisy, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braceability, Inc. | Cedar Falls, IA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bracelab | Raleigh, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg, Inc. | Carlsbad, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bullseye Brace | Hopatcong, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bauerfeind USA, INC. | Atlanta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioSkin LLC | Ashland, OR, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brownmed | Spirit Lake, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cascade Dafo, Inc. | Ferndale, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cast21 Inc. | Evanston, IL, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Compression Solutions, LLC | Charlotte, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products International Inc | Chetek, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dela Incorporated | Ward Hill, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Djo, LLC | Vista, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Fort Worth, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doctor In The House | Blue Bell, PA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR Comfort | Mequon, WI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR.'S Own, LLC | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynasplint Systems, Inc. | Stevensville, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | Powell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Defender Operations, LLC | South Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. Bac Si Imports LLC | Ellensburg, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ehob, Inc. | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ekso Bionics | San Rafael, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elastic Therapy, LLC | Asheboro, NC, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Orthopaedics, Inc. | South El Monte, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergoactives, LLC | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferris MFG. Corp. | Fort Worth, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fit For Life, LLC | Empire State, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Footcare Store LLC | Wellington, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Footura LLC | Cape Canaveral, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forward Motion Medical Systems | Washington, UT, United States | Contract manufacturer, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G-Force Braces | Manchester, NH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global TV Concepts, Ltd. | Coconut Creek, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grace And Able I Inc | Snohomish, WA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guardian Brace, Inc. | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greenwood Marketing LLC | Brandenburg, KY, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hely & Weber | Dfw, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iilabco LLC | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implus Footcare LLC | Durham, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incrediwear Holdings, Inc. | Chico, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ing Source, Inc. | Hickory, NC, United States | Complaint file establishment, Repackager or relabeler, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumental Machine & Development, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iwalkfree, Inc. | Long Beach, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jointsmart LLC | Boyne City, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joint Active Systems, Inc. | Effingham, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kinetic Research | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L&R Usa Inc. | Milwaukee, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Pointique International Ltd. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lamamed Solutions Inc. | Hayward, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Wear Technologies, Inc. | Pompano Beach, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lantz Medical | Merrillville, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MD Orthopaedics | Wayland, IA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEBSTER Inc. | Baltimore, MD, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Specialties, Inc. | Wadesboro, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mueller Sports Medicine, Inc. | Prairie Du Sac, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Myomo, Inc. | Burlington, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotron Medical | Warminster, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NYOrtho | Brooklyn, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ongoing Care Solutions, Inc. | Clearwater, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oppo Medical, Inc. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthocor Medical Inc. | Blaine, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthomerica Products, Inc. | Orlando, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthotic Holdings Inc. | Mesa, AZ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osborn Medical Corporation | Centennial, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare LP | Salt Lake City, UT, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossur Orlando | Orlando, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P.C.P. Champion | Ripley, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Health Supply, LLC. | Cedarburg, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pine Tree Orthopedic Lab, Inc. | Livermore Falls, ME, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pinta Elements | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pittsburgh Plastics MFG., Inc. | Butler, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polygel LLC. | Palmer TWP, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Portland Garment Factory | Portland, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Preferred Industries, Inc. | Fort Lauderdale, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pressure Products Medical Device Manufacturing LLC | Morton, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech International | Raynham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protect3d, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protosthetics | Fargo, ND, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Products | Rocklin, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pure Medical Inc. | Wauwatosa, WI, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Relief Medical | Phoenix, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Products Company LLC | Wadsworth, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resheyp LLC | Solon, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Restorative Care Of America, Inc. | Saint Petersburg, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richardson Products, Inc. | Frankfort, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reflex Group | Oceanside, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saebo, Inc. | Charlotte, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scholl's Wellness Company | Parsippany, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sole Supports, Inc | Lyles, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solo Laboratories | Kutztown, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span Link International LLC | Deer Park, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spio Inc. | Burien, WA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ST&G Usa Corporation / Choi | Brea, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strutz, Inc | Englewd Clfs, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surestep, LLC | South Bend, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Appliance Industries, Inc. | Cincinnati, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shock Doctor, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strassburg Medical, LLC | Lady Lake, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symbiont Logistics, LLC | Phoenix, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Hygenic Company, LLC | Akron, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Soule Co | Lutz, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermotek, Inc. | Flower Mound, TX, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiburon Medical Enterprises | San Jacinto, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Shelf Manufacturing, LLC | Tracy, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trend Medical, LLC | Bethlehem, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trulife, Inc. | Bellingham, WA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tenacious Holdings Inc | Saint Paul, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thrive Orthopedics | Carmel, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thuasne, LLC | Manchester, NH, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thuasne, LLC | Bakersfield, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| U.S. Orthotics, Inc. | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Surgical LLC | Laotto, IN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ultraflex Systems Inc. | Pottstown, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Varitronics | Broomall, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vascular Solutions LLC | Maple Grove, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VISPALEXO, INC dba UBILITY | North Canton, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VQ Orthocare | Vista, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weslacova | North Wilkesboro, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xo Armor Technologies Inc | Auburn, AL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xtreme Orthopedics, LLC D/B/A Flexxline | Fayetteville, AR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zentoes, LLC | Dover, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| pfs med, inc | Springfield, OR, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.