Cleared Traditional

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) (K201257) - FDA 510(k) Clearance

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

K201257 · Arrive Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
330d
Days
Class 2
Risk

K201257 is an FDA 510(k) clearance for the MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400). Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Arrive Systems, Inc. (New Ark, US). The FDA issued a Cleared decision on April 6, 2021 after a review of 330 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.

View all Arrive Systems, Inc. devices

Submission Details

510(k) Number K201257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2020
Decision Date April 06, 2021
Days to Decision 330 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 115d · This submission: 330d
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 Consultant

Iuvo Consulting, LLC
Rhonda Alexander

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K201257.
Legend Pro DMA
K200545 · Pollogen, Ltd. · Oct 2021
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
K202148 · Fit-Pro , Ltd. · Aug 2021
Pain Therapy Device
K202638 · Guangzhou Xinbo Electronic Co., Ltd. · Jul 2021
miha bodytec II
K201975 · Miha Bodytec GmbH · Mar 2021
SLENDERTONE Evolve Abs, Type 735
K203513 · Bio-Medical Research, Ltd. · Feb 2021
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
K210174 · Bemer Int AG · Feb 2021