Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2247290

FEI Number

1000129707

Entity Name

Welwaze Medical, Inc.

City/State/Country

Doral, FL, US

Establishment Address

2800 NW 105 Ave, Doral, FL 33172, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Welwaze Medical, Inc (Owner Number: 10031476)

Owner / Operator Contact Address

2800 NW 105th Avenue, Doral, FL 33172, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K832989

PMA Number

N/A

All Registered Proprietary Names

Celbrea TMD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYA	System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)	Obstetrics/Gynecology	Class 1	884.2982	2010-02-03

Official Correspondent

Francisco Jimenez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Welwaze Medical, 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 2247290. Last updated year: 2026. Please use registration number 2247290 when referencing this establishment in official correspondence.