Cleared Traditional

K151722 - Slim UP ULTRA

K151722 is an FDA 510(k) clearance for Slim UP ULTRA, manufactured by Aime Medical, Inc.. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K151722 · Aime Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
267d
Days
Class 2
Risk

K151722 is an FDA 510(k) clearance for the Slim UP ULTRA. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Aime Medical, Inc. (Largo, US). The FDA issued a Cleared decision on March 18, 2016 after a review of 267 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Aime Medical, Inc. devices

FDA 510(k) Submission Details - K151722

510(k) Number K151722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2015
Decision Date March 18, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 115d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NGX Device Classification - Class 2, Special Controls

Product Code NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - NGX Stimulator, Muscle, Powered, For Muscle Conditioning

All 109
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K151722.
Silk'n MODEL H5003 device
K180279 · Home Skinovations , Ltd. · May 2018
AM-100
K163165 · BTL Industries, Inc. · Feb 2017
SLENDERTONE® Connect Abs, Type 570
K161974 · Bio-Medical Research, Ltd. · Nov 2016
Slendertone connect Abs
K151903 · Bio-Medical Research, Ltd. · Nov 2015
EM25 - glute toning device
K143737 · Hivox Biotek, Inc. · Jul 2015
HIVOX SPOPAD EMS
K141921 · Hivox Biotek, Inc. · Jan 2015