Data / Medical devices / United States / Pdi Works, LLC
Pdi Works, LLC: FDA-registered device maker in Cleveland, TN, United States, 1 510(k) clearance
Pdi Works, LLC is registered with the FDA (registration 3010328269) in Cleveland, TN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010328269
- Address
- 2150 S Lee Hwy, Cleveland, TN, United States, 37311
- Owner or operator
- PDI Works, LLC (10044465)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- June 15, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 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 |
|---|---|---|---|---|---|---|
| March 1, 2012 | K113037 | PAIN-AID | NUH | Substantially Equivalent | Pdi Works, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Analyzer, Body Composition, Exempt
Updated March 1, 2012. 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.