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510(k) Data Aggregation
K Number
K070541Device Name
IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
Manufacturer
IVIVI TECHNOLOGIES, INC.
Date Cleared
2008-12-11
(654 days)
Product Code
ILX
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
IVIVI TECHNOLOGIES, INC.
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
SofPulse (912-M10, Roma3 and Torino II) devices are shortwave diathermy medical devices which apply 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 SofPulse models were designed to deposit mean radio frequency energy in tissue which is equivalent to that of the predicate MRT device. All of the SofPulse options deliver the RF signal to the tissue farget via inductive coupling with an applicator coil. SofPulse devices are portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.
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