Data / Medical devices / United States / PDC Restorer, LLC
PDC Restorer, LLC: FDA-registered device maker in Indianapolis, IN, United States, 1 510(k) clearance
PDC Restorer, LLC is registered with the FDA (registration 3010984291) in Indianapolis, IN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 20, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010984291
- Address
- 6330 East 75th Street Suite 128, Indianapolis, IN, United States, 46250
- Owner or operator
- Advanced Healing Initiative LLC (10089872)
- Roles
- Repackager or relabeler
- First device listed
- January 17, 2024
- Registered through
- 2026
- Brand names listed
- PDC Restorer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 20, 2008 | K080304 | PRO TENS, MODEL WL-240 RX | GZJ | Substantially Equivalent | Well-Life Healthcare Limited | accessdata.fda.gov |
Compare with other makers
Updated June 20, 2008. 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.