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510(k) Data Aggregation
K Number
K151722Device Name
Slim UP ULTRA
Manufacturer
Date Cleared
2016-03-18
(267 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
AIME MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Slim UP® ULTRA is indicated for the use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrode for the purpose of improvement of muscle tone of buttocks muscles.
Device Description
Slim UP® ULTRA is a new beauty appliance that works on the principles of Electrostimulation. Slim UP® is used in environments such as Health Spa's and Beauty Salons. Slim UP® ULTRA has following major components: Main power switch, Control panel, Infrared unit, Distribution of electro-stimulation channels. Slim UP® ULTRA electrostimulation section has 8 channels for body electrostimulation with compensated two-phase rectangular waveform, with individual intensity adjustment and 5 different multi-phase treatment programs diversified to meet the needs of the single case. Slim UP® ULTRA infrared section has 6 infrared ray sources housed in a height-adjustable, mobile arm that adapts to any couch, ensuring the ideal working distance is maintained at all times. IR source is used for patient comfort only. It does not have any therapeutic effect. Slim UP® ULTRA is a latest-generation machine occupying only half a square meter. It can be located in any booth, can be adapted to any bed and can be moved anywhere.
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