Data / Medical devices / United States / GWR Medical, Inc.
GWR Medical, Inc.: FDA-registered device maker in Chadds Ford, PA, United States, 1 510(k) clearance
GWR Medical, Inc. is registered with the FDA (registration 3008847017) in Chadds Ford, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 7, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008847017
- Address
- 4 Hillman Dr Suite 106, Chadds Ford, PA, United States, 19317
- Owner or operator
- GWR Medical, Inc. (10035265)
- Roles
- Specification developer
- First device listed
- February 16, 2011
- Registered through
- 2026
- Brand names listed
- O2Boot, O2Sacral
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Oxygen, Topical, Extremity | KPJ | 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 |
|---|---|---|---|---|---|---|
| November 7, 1997 | K971507 | O2 BOOT | KPJ | Substantially Equivalent | Gwr Medical, Llp | accessdata.fda.gov |
Compare with other makers
Updated November 7, 1997. 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.