Data / Medical devices / United States / Better Water, Inc.
Better Water, Inc.: FDA-registered device maker in Smyrna, TN, United States, 3 510(k) clearances
Better Water, Inc. is registered with the FDA (registration 1055109) in Smyrna, TN, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 16, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1055109
- FEI number
- 1000112932
- Address
- 698 Swan Dr, Smyrna, TN, United States, 37167
- Owner or operator
- BETTER WATER, INC. (9004690)
- Roles
- Manufacturer
- First device listed
- July 7, 1992
- Registered through
- 2026
- Brand names listed
- BiCarbonate Mixer Unit, Medi-port Portable Reverse Osmosis Unit, Water Purification System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Subsystem, Water Purification | FIP | 2 | Manufacturer | accessdata.fda.gov |
| Tank, Holding, Dialysis | FIN | 2 | Manufacturer | 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 16, 1999 | K992793 | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM | FIN | Substantially Equivalent | Better Water, Inc. | accessdata.fda.gov |
| January 24, 1996 | K954928 | PORTABLE REVERSE OSMOSIS MACHINE | FIP | Substantially Equivalent | Better Water, Inc. | accessdata.fda.gov |
| June 13, 1995 | K920186 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent | Better Water, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 16, 1999. 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.