Cleared Traditional

K181419 - FLIX-EMS (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181419 · Casgarum Investment, S.L. · Physical Medicine device
May 2019
Decision
348d
Days
Class 2
Risk

K181419 is an FDA 510(k) clearance for the FLIX-EMS. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Casgarum Investment, S.L. (Illescas, ES). The FDA issued a Cleared decision on May 14, 2019 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

Submission Details

510(k) Number K181419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2018
Decision Date May 14, 2019
Days to Decision 348 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 151d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 22
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K181419.
Zionic Pro Max (EMS)
K253636 · Termosalud S.L. · Mar 2026
CoolTone
K253408 · Zimmer Medizinsysteme GmbH · Jan 2026
Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
K252154 · Guangzhou Longest Medical Technology Co., Ltd. · Dec 2025
Motive™ Muscle Stimulator for Lower Back (OT01-1003)
K253478 · Motive Health, Inc. · Nov 2025
truFlex
K251594 · Syrma Johari Medtech Limited · Aug 2025
TENS and EMS Unit
K251706 · Changsha Anxiang Medical Technology Co., Ltd. · Jul 2025