Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3041843469

FEI Number

3041843469

Entity Name

BREATHEWAVE TECHNOLOGIES INC.

City/State/Country

Edgewater, NJ, US

Establishment Address

1255 River Rd, Edgewater, NJ 07020, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Breathewave Technologies Inc. (Owner Number: 10085672)

Owner / Operator Contact Address

1255 RIVER ROAD, Edgewater, NJ 07020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Breathewave Nasal Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2022-07-18

Official Correspondent

David Axelrad

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Breathewave Technologies 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 3041843469. Last updated year: 2026. Please use registration number 3041843469 when referencing this establishment in official correspondence.