Data / Medical devices / United States / Thuasne, LLC
Thuasne, LLC: FDA-registered device maker in Hamlet, NC, United States, 1 510(k) clearance
Thuasne, LLC is registered with the FDA (registration 1064876) in Hamlet, NC, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 24, 2009. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1064876
- FEI number
- 3003185541
- Address
- 167 Marks Creek Ln, Hamlet, NC, United States, 28345
- Owner or operator
- Thuasne, LLC (9033323)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 20, 2006
- Registered through
- 2027
- Brand names listed
- Core-Sport, Core-Spun by Therafirm 15-20, 20-30, 30-40 mmHg Trouser Socks and Thigh Highs (non-X-Static), Core-spun by Therafirm, EASE by Therafirm, Ease Adjust by Therafirm, Ease Opaque 15-20, 20-30, 30-40mmHg (Knee Highs, Thigh Highs, Pantyhose, Trouser Socks), Ease by Therafirm 20-30mmHg & 30-40mmHg Lymphedema Arm Sleeve, Glove, and Gauntlet, Ease by Therafirm Microfiber Tights 15-20mmHg, 20-30mmHg and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Binder, Medical, Therapeutic | MDR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 24, 2009 | K091141 | THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS | DWL | Substantially Equivalent | Knit-Rite, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stocking, Medical Support (For General Medical Purposes)
- All makers of Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- All makers of Binder, Medical, Therapeutic
Updated July 24, 2009. 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.