Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016829704

FEI Number

3016829704

Entity Name

Nuvo Intl Group Inc.

City/State/Country

Aventura, FL, US

Establishment Address

2980 NE 207TH ST., Aventura, FL 33180, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nuvo Intl Group Inc (Owner Number: 10071666)

Owner / Operator Contact Address

2980 NE 207th St., Aventura, FL 33180, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191401

PMA Number

N/A

All Registered Proprietary Names

PregSense

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LQK	Home Uterine Activity Monitor	Obstetrics/Gynecology	Class 2	884.2730	2020-04-23

Official Correspondent

Ahava Stein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nuvo Intl Group 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 3016829704. Last updated year: 2026. Please use registration number 3016829704 when referencing this establishment in official correspondence.