DEVICE: Ibramed (07898966442964)
Device Identifier (DI) Information
Ibramed
Hooke
In Commercial Distribution
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Hooke
In Commercial Distribution
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Hooke is a microcontrolled, non-ablative, high frequency radiofrequency equipment (27.12MHz), which can be used in the areas of facial and body aesthetics. The equipment has four applicators: three radiofrequency applicators, FACIAL (small bipolar applicator), BIPOLAR (body bipolar applicator) and MONOPOLAR (body monopolar applicator) and a COOLING applicator (air-cooled) for thermal comfort and preservation of the epidermis.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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IRQ | Unit, Heating, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3eb41c89-100a-4862-82b9-d8e19ba53eae
March 05, 2025
1
February 25, 2025
March 05, 2025
1
February 25, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined