Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011457702

FEI Number

3011457702

Entity Name

ONTEL PRODUCTS CORPORATION

City/State/Country

Fairfield, NJ, US

Establishment Address

21 LAW DR, Fairfield, NJ 07004, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OnTel Products Corp (Owner Number: 10048404)

Owner / Operator Contact Address

21 Law Drive, Fairfield, NJ 07004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Foot Angel Compression Ankle Sleeve Miracle Socks Posture Doctor Miracle Dry-Eye Relief Miracle Headache Relief GelRX Water Flosser Total Care Cleaning Heads Miracle Smile Water Flosser Head Pack MO Miracle Smile Head Pack MO Water Flosser Replacement Heads Miracle Foot Relief Miracle Arch Relief Safe & Healthy Big Vision Non Prescription Magnification Eyewear Mighty Sight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2015-01-23
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2019-06-13
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-06-01
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-08-21
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-07-11
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-05-10
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2015-01-22

Official Correspondent

Lisa Siervo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OnTel Products Corp

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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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3007576486	HERITAGE HOSIERY INC	Chattanooga, TN, US
3016932181	JIN MINNG INDUSTRIAL CO, LTD.	Shetou Township Changhua, TW
3010280404	YIWU QUINT HOSIERY CO., LTD	YIWU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011457702. Last updated year: 2026. Please use registration number 3011457702 when referencing this establishment in official correspondence.