Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032900656

FEI Number

3032900656

Entity Name

CAREWELL FAMILY, INC

City/State/Country

Coral Gables, FL, US

Establishment Address

321 Romano Ave, Coral Gables, FL 33134, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Carewell Family, Inc (Owner Number: 10091695)

Owner / Operator Contact Address

321 Romano Ave, Coral Gables, FL 33134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Carewell Brand model-Overnight and Heavy- Full Fit Coverage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2024-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Carewell Family, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032900656. Last updated year: 2026. Please use registration number 3032900656 when referencing this establishment in official correspondence.