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510(k) Data Aggregation
K Number
K121338Device Name
ZEOBI
Manufacturer
IVIVI HEALTH SCIENCE, LLC
Date Cleared
2012-07-27
(85 days)
Product Code
ILX
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
IVIVI HEALTH SCIENCE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
Device Description
The Zeobi is a portable battery powered non-invasive therapy device which applies to the body electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The Zeobi was designed to deposit mean radio frequency energy in tissue which is equivalent to that of the Torino II. The Zeobi delivers the RF signal to the tissue target via inductive coupling with an applicator coil. The device is portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.
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