Data / Medical devices / United States / i-Health, Inc.
i-Health, Inc.: FDA-registered device maker in Enfield, CT, United States, 2 510(k) clearances
i-Health, Inc. is registered with the FDA (registration 1221895) in Enfield, CT, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221895
- Address
- a division of dsm-firmenich 25 Bacon Road, Suite 102, Enfield, CT, United States, 06082
- Owner or operator
- i-Health, Inc., a division of DSM-FIRMENICH (10026311)
- Roles
- Complaint file establishment
- First device listed
- February 10, 2016
- Registered through
- 2026
- Brand names listed
- AZO Test Strips(R), AZO Vaginal Moisturizer Suppositories, AZO Vaginal pH Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Complaint file establishment | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment | accessdata.fda.gov |
| Paper, Obstetric Ph | LNW | 1 | Complaint file establishment | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Complaint file establishment | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| April 1, 2026 | K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | NUC | Substantially Equivalent | Hudi Pharma Srl | accessdata.fda.gov |
| February 17, 2011 | K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | JMT | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Urine Leukocyte
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Paper, Obstetric Ph
- All makers of Lubricant, Personal
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Updated April 1, 2026. 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.