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510(k) Data Aggregation
K Number
K242553Device Name
MIRARI® Cold Plasma System ( GV-M2-01)
Manufacturer
General Vibronics, Inc.
Date Cleared
2024-11-21
(86 days)
Product Code
PBX, GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
General Vibronics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MIRARI® Cold Plasma System provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation.
Device Description
The Mirari Cold Plasma System is a portable, hand-held device that emits RF energy at 80kHz. The system is comprised of a battery-operated RF generator, a rechargeable power supply powered by a pair of lithium batteries and a plasma array which is placed in fleece pouch. The plasma array is then placed in a fleece pouch which is then placed on the RF energy is emitted through the array..
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