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510(k) Data Aggregation
K Number
K240991Device Name
eMVFit (MVF-10M)
Manufacturer
Weero Co., Ltd.
Date Cleared
2024-10-09
(181 days)
Product Code
PBX, GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Weero Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The eMVFit (MVF-10M) Radio frequency is used for:
· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
· Temporary reduction in the appearance of cellulite.
Device Description
eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable.
eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode.
MULTI mode has RF and EMS functions that use the MULTI handpiece.
In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface.
In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43°C.
EMS mode has an EMS function that uses the EMS handpiece.
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