Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005404127

FEI Number

3005404127

Entity Name

Zona Health, Inc.

City/State/Country

Montgomery, AL, US

Establishment Address

8416 Crossland Loop, Montgomery, AL 36117, US

Establishment Type(s)

Manufacture Device in the United States for Export Only,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Zona Health, Inc. (Owner Number: 9077483)

Owner / Operator Contact Address

8416 Crossland Loop, Montgomery, AL 36117, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CARDIOGRIP ZONA PLUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2005-09-13

Official Correspondent

Mark Young

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zona Health, 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 3005404127. Last updated year: 2026. Please use registration number 3005404127 when referencing this establishment in official correspondence.