Data / Medical devices / Orthosis, Lumbar / United States
FDA-registered makers of Orthosis, Lumbar in the United States: 62 establishments
62 establishments in the United States are registered with the FDA to make Orthosis, Lumbar (product code IQE). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Orthosis, Lumbar
- Product code
- IQE
- Country
- United States
Makers of Orthosis, Lumbar in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Air A Med, LLC | Fort Myers, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alex Orthopedic, Inc. | Grand Prairie, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amazing Brace, LLC | Tampa, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Medical Products LLC | Eatontown, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Medical Products, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barbaras Development, Inc. | Thousand Oaks, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becker Orthopedic Appliance Co. | Troy, MI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bird & Cronin, LLC | Eagan, MN, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bishop | Shreveport, LA, United States | Manufacturer | 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 | |
| Breg, Inc. | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, 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 | |
| Beocare Inc., Hudson | Hudson, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfortland International, LLC | Mebane, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products Intl., Inc. | Osceola, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products International Inc | Chetek, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dela Incorporated | Ward Hill, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR. Brace LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical Supply Of New York, LLC | Hendersonville, TN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Orthopaedics, Inc. | South El Monte, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hely & Weber | Dfw, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideavillage Products Corp. | Wayne, NJ, 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 | |
| Innovative Medical Equipment | Beachwood, OH, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kenad SG Medical, Inc. | Bartlett, TN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Pointique International Ltd. | Seattle, WA, United States | Specification developer | 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 | |
| Manamed LLC | Denton, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Motion Therapeutics | Folsom, CA, United States | Manufacturer | 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 | |
| Oppo Medical, Inc. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optec Usa, Inc. | Lawrenceville, GA, United States | Manufacturer | 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, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare LP | Salt Lake City, UT, 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 | |
| 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 | |
| Relief Medical | Phoenix, AZ, 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 | |
| Rival Technologies, LLC | Phoenix, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secured Ortho Manufacturing Of America, LLC | Deer Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span Link International LLC | Deer Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spinal Technology, LLC | West Yarmouth, MA, United States | Contract manufacturer, 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 | |
| Shock Doctor, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spinal Systems, LLC | Louisville, KY, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Pettibon System | Chehalis, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiburon Medical Enterprises | San Jacinto, 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 | |
| Thuasne, LLC | Manchester, NH, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unite Medical, LLC | Lithia Springs, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Surgical LLC | Laotto, IN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitaform, Inc. | Dana Point, CA, United States | Repackager or relabeler, 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 |
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.