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510(k) Data Aggregation
K Number
K232966Device Name
FISIOWARM 7.0
Manufacturer
Golden Star Srl
Date Cleared
2024-12-26
(462 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Golden Star Srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a temporary reduction in the appearance of cellulite.
Device Description
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are active and therapeutic medical devices that perform their function by releasing energy to the human body.
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