Data / Medical devices / United States / R.G. Enterprises (u.s.a.), Inc.
R.G. Enterprises (u.s.a.), Inc.: FDA-registered device maker in Madison Heights, MI, United States, 3 510(k) clearances
R.G. Enterprises (u.s.a.), Inc. is registered with the FDA (registration 1835242) in Madison Heights, MI, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 5, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1835242
- FEI number
- 1000518606
- Address
- 26010 Pinehurst Dr, Madison Heights, MI, United States, 48071
- Owner or operator
- R.G. ENTERPRISES (U.S.A.), INC. (9024233)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- November 7, 2007
- Registered through
- 2026
- Brand names listed
- DataTherm II Continuous Temperature Monitor, Geratherm SolarTherm Speed Digital Thermometer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Thermometer, Clinical Mercury | FLK | 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 5, 2007 | K070878 | DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 | FLL | Substantially Equivalent | Rg Medical Diagnostics | accessdata.fda.gov |
| February 4, 1998 | K974195 | FLEXIBLE TIP DIGITAL THERMOMETER | FLL | Substantially Equivalent | K-Jump Health Co., Ltd. | accessdata.fda.gov |
| March 25, 1996 | K960224 | GERATHERM MERCUIRY FREE CLINICAL THERMOMETER | FLK | Substantially Equivalent | Rg Ent., Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 5, 2007. 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.