Ibramed

Basic Information

• Brand Name: Ibramed
• Primary DI: 07898966442933
• Version / Model: Cryotecar
• Company Name: Ibramed Industria Brasileira de Equipamentos Medicos Eir
• Labeler DUNS: 903359565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-25
• Public Version: 1
• Public Version Date: 2025-03-05
• Public Version Status: New
• Public Device Record Key: 58de5ee1-3a16-4bff-994c-7a6f601df303

Device Description

The CRYOTECAR equipment is designed for therapies including Tecartherapy, Radiofrequency, Cryotecartherapy, Cryofrequency, and Fractional techniques. These non-invasive treatments use capacitive and resistive applicators to promote tissue heating, aiding in the temporary improvement of sagging skin, cellulite, and localized fat. Cryotecartherapy and Cryofrequency feature cooled tips for a more comfortable temperature increase. The device supports monopolar and bipolar modes, with capacitive tips for superficial heating and resistive tips for deeper tissue treatment. Fractional Cryofrequency and Radiofrequency create microscopic thermal lesions, enhancing skin tightening in facial and body aesthetics.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRQ	Unit, Heating, Powered	Physical Medicine	890.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35538	Freestanding electric massager	An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898966442933	GS1