Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014449259

FEI Number

3014449259

Entity Name

NUVOMED INC

City/State/Country

Broadview, IL, US

Establishment Address

2101 W 21st St, Broadview, IL 60155, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Nuvomed Inc (Owner Number: 10059387)

Owner / Operator Contact Address

2101 W 21 street, Broadview, IL 60155, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Air Massager Great Health Wireless Audio Sunglasses Hearing Aid Hot & Cold Therapy Sleeve Hot & Cold Therapy Pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-10-18
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-14
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2022-08-11
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2026-02-13
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2021-03-05
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-11-09
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-03-19

Official Correspondent

Umar Aziz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nuvomed Inc

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014449259. Last updated year: 2026. Please use registration number 3014449259 when referencing this establishment in official correspondence.