Data / Medical devices / United States / Medi Usa, LP
Medi Usa, LP: FDA-registered device maker in Whitsett, NC, United States, 2 510(k) clearances
Medi Usa, LP is registered with the FDA (registration 1450371) in Whitsett, NC, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450371
- Address
- 6481 Franz Warner Pkwy, Whitsett, NC, United States, 27377
- Owner or operator
- MEDI USA, LP (1450371)
- Roles
- Specification developer
- First device listed
- December 22, 2016
- Registered through
- 2026
- Brand names listed
- Brace Liner, Circaid Profile, Circaid Reduction Kit Glove, Circaid Reduction Kit Toe Cap, Compressive Undersock, Doc Ortho relief, Duomed Advantage, Duomed Relax and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Binder, Elastic | KMO | 1 | Specification developer | accessdata.fda.gov |
| Binder, Medical, Therapeutic | MDR | 1 | Specification developer | accessdata.fda.gov |
| Foot Wrap For Treating Restless Leg Syndrome Symptoms | OTX | 1 | Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Specification developer | accessdata.fda.gov |
| Stocking, Elastic | ILG | 1 | Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Specification developer | 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 7, 2022 | K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | JOW | Substantially Equivalent | Medi USA, LP | accessdata.fda.gov |
| January 25, 2019 | K183631 | medi pneumatic compression system (pcs) brio (Model 651) | JOW | Substantially Equivalent | Medi USA, LP | accessdata.fda.gov |
Compare with other makers
- All makers of Binder, Medical, Therapeutic
- All makers of Sleeve, Limb, Compressible
- All makers of Stocking, Elastic
- 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 Foot Wrap For Treating Restless Leg Syndrome Symptoms
Updated July 7, 2022. 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.