Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1823393

FEI Number

1823393

Entity Name

OXYGEN THERAPY INSTITUTE

City/State/Country

Jacksonville, FL, US

Establishment Address

5971 Powers Ave # 8, Jacksonville, FL 32217, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LifeSafe Services (Owner Number: 1823393)

Owner / Operator Contact Address

5971 POWERS AVE # 8, --, Jacksonville, FL 32217, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OXYGEN THERAPY INSTITUTE INC. OXYGEN REGULATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-01-23

Official Correspondent

Christine Hoene

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LifeSafe Services

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
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Similar Registrations

Registration Number	Establishment Name	Location
3017365972	WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH	Hamburg, DE
1924066	Allied Medical LLC	Earth City, MO, US
1625392	INTERNATIONAL BIOMEDICAL, LTD.	AUSTIN, TX, US
8044169	PLAXTRON INDUSTRIAL (M) SDN. BHD.	IPOH Perak, MY
9610861	O-TWO MEDICAL TECHNOLOGIES, INC.	Brampton Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1823393. Last updated year: 2026. Please use registration number 1823393 when referencing this establishment in official correspondence.