Cleared Special

K122414 - AB COMMAND DUAL CHANNEL FITNESS BELT

K122414 is an FDA 510(k) clearance for AB COMMAND DUAL CHANNEL FITNESS BELT, manufactured by Leto Enterprises Incorporation. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Special 510(k) pathway after a 135-day FDA review.

K122414 · Leto Enterprises Incorporation · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
135d
Days
Class 2
Risk

K122414 is an FDA 510(k) clearance for the AB COMMAND DUAL CHANNEL FITNESS BELT. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Leto Enterprises Incorporation (Shenzhen, CN). The FDA issued a Cleared decision on December 21, 2012 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122414

510(k) Number K122414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date December 21, 2012
Days to Decision 135 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 116d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

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 162
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K122414.
ION MAGNUM GENIUS
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K121719 · Hong Qiangxing (Shenzhen) Electronics Limited · May 2013
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K111781 · Well Brain International , Ltd. · Jul 2012
CONTOUR TECHNOLOGY MUSCLE STIMULATOR
K111476 · Contour Technology · May 2012
MINI MASSEUSE
K110057 · Mj Specialty Retail · Oct 2011
K122414 · AB COMMAND DUAL CHANNEL FITNESS BELT
Download PDF FDA Summary Leto Enterprises Inco…