Search Results
Found 1 results
510(k) Data Aggregation
K Number
K191202Device Name
CAPENERGY - C100, C200, C300, C400, C50
Manufacturer
Capenergy Medical SL
Date Cleared
2020-02-11
(281 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Capenergy Medical SL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CAPENERGY C Devices - C100, C200, C300, C400, C50 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating electrical currents applied to the patient by using electrodes or plates. The RF current is coupled to the human body by means of an insulated or non-insulated electrode -the active accessory-, which together with the body and the return electrode -the passive plate- forms an electric circuit, which allows the passage of RF current through the body areas situated between the two electrodes. The number of available channels on the different models of the CAPENERGY product range varies from one to four. When a model has several channels, these operate independently. Each channel has a keyboard that lets you manage the parameters of frequency and channel power. It also has two light columns that report the selected power level and a qualitative indication of the power delivered by the channel. The user interface has a screen and a keyboard that allows you to manage several functions: timer, connected accessories management, state management, energy and temperature measurements and alarms. The user interface is organized in a menu system that makes it possible to choose between the different features available on the equipment.
Ask a Question
Page 1 of 1