Cleared Traditional

Visionbody (K222386) - FDA 510(k) Clearance

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

K222386 · Vb Technologies AG · Physical Medicine device
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Feb 2023
Decision
200d
Days
Class 2
Risk

K222386 is an FDA 510(k) clearance for the Visionbody. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Vb Technologies AG (Zug, CH). The FDA issued a Cleared decision on February 24, 2023 after a review of 200 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 Vb Technologies AG devices

Submission Details

510(k) Number K222386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2022
Decision Date February 24, 2023
Days to Decision 200 days
Submission Type Traditional
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
85d slower than avg
Panel avg: 115d · This submission: 200d
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 93
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K222386.
Bemer Therapy System Evo
K231368 · Bemer Int AG · 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
Neuro20 Pro System
K223797 · Neuro20 Technologies · Feb 2023
XBody Go USA, XBody Pro USA
K221200 · Xbody Hungary Kft. · Jan 2023
truSculpt flex
K212866 · Johari Digital Healthcare Limited · Dec 2022