Data / Medical devices / United States / Elite Medical Supply Of New York, LLC
Elite Medical Supply Of New York, LLC: FDA-registered device maker in Hendersonville, TN, United States, 1 510(k) clearance
Elite Medical Supply Of New York, LLC is registered with the FDA (registration 3013375723) in Hendersonville, TN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 18, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013375723
- Address
- 40-C Industrial Park Drive, Hendersonville, TN, United States, 37075
- Owner or operator
- Elite Medical Supply of New York, LLC (10039893)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 19, 2012
- Registered through
- 2026
- Brand names listed
- Elite 456/457 TLSO, Elite 631/648 LSO, Elite 637/650 LSO, Elite Multi Mode Stimulator Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Lumbar | IQE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 18, 2004 | K042881 | PMD-2000 INTERFERENTIAL STIMULATOR | IPF | Substantially Equivalent | Phoenix Medical Devices, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Lumbar
- All makers of Orthosis, Thoracic
- All makers of Stimulator, Muscle, Powered
Updated November 18, 2004. 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.