Slim UP ULTRA

Stimulator, Muscle, Powered, For Muscle Conditioning

AIME MEDICAL INC

The following data is part of a premarket notification filed by Aime Medical Inc with the FDA for Slim Up Ultra.

Pre-market Notification Details

Device IDK151722
510k NumberK151722
Device Name:Slim UP ULTRA
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant AIME MEDICAL INC 1258 WEST BAY DRIVE, SUITE F Largo,  FL  33770
ContactPaul Guilbaud
CorrespondentJohn O'brien
AJW TECHNOLOGY CONSULTANTS, INC. 445 APOLLO BEACH BLVD Apollo Beach,  FL  33572
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2015-06-25
Decision Date2016-03-18
Summary:summary

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