Data / Medical devices / United States / Djo, LLC
Djo, LLC: FDA-registered device maker in Fort Worth, TX, United States, 1 510(k) clearance
Djo, LLC is registered with the FDA (registration 3014694377) in Fort Worth, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 21, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014694377
- Address
- 3300 Eagle Parkway, Fort Worth, TX, United States, 76177
- Owner or operator
- DJO, LLC (9015378)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 19, 1998
- Registered through
- 2026
- Brand names listed
- A2 WRIST BRACE, ABDUCTED THUMB SPICA, AC SPORT BRACE, ACROMIOCLAVICULAR BRACE-UNIV, ACTYTOE FOOT BRACE, ACTYTOE LIFT, ACTYTOE NIGHT SPLINT, ADVANTAGE STABILIZING ELASTIC WRIST and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Complaint file establishment | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 21, 2021 | K202839 | Overlapped Compression Therapy | JOW | Substantially Equivalent | Jkh Health Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 21, 2021. 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.