ONE DIRECT HEALTH

FDA Device Registration & Listing · Marietta, GA, US · Registration 3013551163

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
3013551163
FEI Number
3013551163
Entity Name
ONE DIRECT HEALTH
City/State/Country
Marietta, GA, US
Establishment Address
2270 Northwest Pkwy. SE, #160, Marietta, GA 30067, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ONE DIRECT HEALTH NETWORK (Owner Number: 10054409)
Owner / Operator Contact Address
2270 Northwest Pkwy. SE, #160, Marietta, GA 30067, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

T-Rex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BXB Exerciser, Powered Physical Medicine Class 1 890.5380 2017-03-15

Official Correspondent

Cindy Clement

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ONE DIRECT HEALTH NETWORK
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 3013551163. Last updated year: 2026. Please use registration number 3013551163 when referencing this establishment in official correspondence.
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