Cleared Traditional

Bemer Therapy System Evo (K231368) - FDA 510(k) Clearance

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

K231368 · Bemer Int AG · Physical Medicine device
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Jun 2023
Decision
29d
Days
Class 2
Risk

K231368 is an FDA 510(k) clearance for the Bemer Therapy System Evo. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Bemer Int AG (Triesen, LI). The FDA issued a Cleared decision on June 9, 2023 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bemer Int AG devices

Submission Details

510(k) Number K231368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2023
Decision Date June 09, 2023
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 93
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K231368.
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K220938 · Aura Wellness, LLC · Aug 2023
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K231318 · Beijing Adss Development Co., Ltd. · Jul 2023
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K231136 · Shenzhen Kelutongda Industrial Co., Ltd. · Jun 2023
Gnesis EMS Plus
K230261 · Creative Fitness Developments S.L. · Jun 2023
Powered Muscle Stimulator (Model name:MagGraver F200)
K222875 · Nanjing Vishee Medical Technology Co., Ltd. · Mar 2023
Visionbody
K222386 · Vb Technologies AG · Feb 2023