Data / Medical devices / United States / Global Wholehealth Partners Corp
Global Wholehealth Partners Corp: FDA-registered device maker in Fontana, CA, United States, 2 510(k) clearances
Global Wholehealth Partners Corp is registered with the FDA (registration 3021448148) in Fontana, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 10, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021448148
- Address
- 8025 Summer Place Street, Fontana, CA, United States, 92336
- Owner or operator
- GLOBAL WHOLEHEALTH PARTNERS CORP (10084046)
- Roles
- Repackager or relabeler
- First device listed
- January 12, 2022
- Registered through
- 2026
- Brand names listed
- Rapid Onsite Test, SilverStream
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 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 |
|---|---|---|---|---|---|---|
| December 10, 2009 | K093227 | SILVERSTREAM AND DERMASEPT | FRO | Substantially Equivalent | Enzysurge , Ltd. | accessdata.fda.gov |
| February 16, 1999 | K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | LCX | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 10, 2009. 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.