Data / Medical devices / Brazil / Ibramed Industria Brasileira de Equipamentos Medicos Ltda

Ibramed Industria Brasileira de Equipamentos Medicos Ltda: FDA-registered device maker in Amparo Sao Paulo, Brazil, 6 510(k) clearances

Name: Ibramed Industria Brasileira de Equipamentos Medicos Ltda FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ibramed Industria Brasileira de Equipamentos Medicos Ltda is registered with the FDA (registration 3010362721) in Amparo Sao Paulo, Brazil. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 11, 2021. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3010362721
Address: Ave Dr. Carlos Burgos 2800 Jardim Italia, Amparo Sao Paulo, Brazil, 13901-080
Owner or operator: Ibramed Industria Brasileira de Equipamentos Medicos Ltda (10043478)
Roles: Manufacturer
First device listed: June 20, 2013
Registered through: 2026
Brand names listed: AUSSIE SPORT, CELLEBRA, CELLEBRA Compact 1MHz, CELLEBRA Compact 3MHz, CELLEBRA III, Cryotecar, Dermotonus Esthetic, Dermotonus Slim and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Manufacturer	accessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	2	Manufacturer	accessdata.fda.gov
Unit, Heating, Powered	IRQ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 11, 2021	K210572	Neurodyn V2.0, Neurodyn Aussie V2.0	IPF	Substantially Equivalent	Ibramed Equipamentos Medicos	accessdata.fda.gov
July 3, 2014	K131923	NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS	GZI	Substantially Equivalent	Techlink International	accessdata.fda.gov
April 29, 2014	K131917	NEURODYN COMPACT, NEURODYN II	IPF	Substantially Equivalent	Ibramed Equipamentos Medicos	accessdata.fda.gov
January 27, 2014	K131309	SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ	IMI	Substantially Equivalent	Ibramed Equipamentos Medicos	accessdata.fda.gov
January 9, 2014	K130888	SONOPULSE/ SONOPULSE III	IMI	Substantially Equivalent	Ibramed- Industria Brazileria DE Equipamentos Medi	accessdata.fda.gov
November 26, 2013	K131629	NEURODYN MULTIWAVE, AUSSIE SPORT	IPF	Substantially Equivalent	Ibramed Equipamentos Medicos	accessdata.fda.gov

Compare with other makers

Updated May 11, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.