i-Health, Inc.

FDA Device Registration & Listing · Enfield, CT, US · Registration 1221895

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1221895
FEI Number
1221895
Entity Name
i-Health, Inc.
City/State/Country
Enfield, CT, US
Establishment Address
a division of dsm-firmenich, 25 Bacon Road, Suite 102, Enfield, CT 06082, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
i-Health, Inc., a division of DSM-FIRMENICH (Owner Number: 10026311)
Owner / Operator Contact Address
2 Corporate Drive, Suite 445, Shelton, CT 06484, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K260007
PMA Number
N/A

All Registered Proprietary Names

AZO Vaginal Moisturizer Suppositories

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2026-06-19

Official Correspondent

Julie Bagley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

i-Health, Inc., a division of DSM-FIRMENICH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K050212 Qualis, Inc. PERSONAL WARMING JELLY 2005-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221895. Last updated year: 2026. Please use registration number 1221895 when referencing this establishment in official correspondence.
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