Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010362721

FEI Number

3010362721

Entity Name

Ibramed Industria Brasileira de Equipamentos Medicos Ltda

City/State/Country

Amparo Sao Paulo, BR

Establishment Address

Ave Dr. Carlos Burgos 2800, Jardim Italia, Amparo Sao Paulo 13901-080, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ibramed Industria Brasileira de Equipamentos Medicos Ltda (Owner Number: 10043478)

Owner / Operator Contact Address

Ave Dr. Carlos Burgos 2800, Jardim Italia, Amparo, BR-SP 13901-080, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131917

PMA Number

N/A

All Registered Proprietary Names

Sonopulse III Sonopulse CELLEBRA CELLEBRA III Sonopulse Compact 1MHz Sonopulse Compact 3MHz CELLEBRA Compact 3MHz CELLEBRA Compact 1MHz Neurodyn Aussie V2 Neurodyn V2 Dermotonus Slim Dermotonus Esthetic THORK SHOCK WAVE MODELLATA Neartek Dermotonus Esthetic Dermotonus Slim AUSSIE SPORT NEURODYN MULTIWAVE NEUROTONUS MULTIWAVE NEURODYN PORTABLE TENS NEURODYN PORTABLE TENS NFES NEUROTONUS PORTABLE TENS NEUROTONUS PORTABLE TENS FES Neurodyn Compact Neurodn II NEUROTONUS Compact NEUROTONUS II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2014-01-15
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2014-03-18
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-05-12
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2013-06-20
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2013-06-20
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2014-01-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-01-15
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2014-01-15
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-01-15
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2017-02-13
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2017-02-13
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2014-05-19
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-05-19
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-05-19

Official Correspondent

Ricardo Souza

US Agent Details

Rodrigo Abreu Business: United Regulatory & Logistics LLC Email: rabreu@unitedregulatory.com Phone: (786) 2667900

Related Public Records

Same Entity

Ibramed Industria Brasileira de Equipamentos Medicos Ltda

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
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04
K964028	Mettler Electronics Corp.	SYS STIM 226	1997-02-03

Similar Registrations

Registration Number	Establishment Name	Location
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN
3014315574	BRH MEDICAL LTD	Jerusalem, IL
1313525	Bausch & Lomb Incorporated	Rochester, NY, US
8010720	ZIMMER MEDIZINSYSTEME GMBH	NEU-ULM Bavaria, DE
3013069546	ASCENTRON, INC.	White City, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010362721. Last updated year: 2026. Please use registration number 3010362721 when referencing this establishment in official correspondence.