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K Number
K201257
Device Name
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Manufacturer
Arrive Systems Inc
Date Cleared
2021-04-06

(330 days)

Product Code
NGX
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a powered muscle stimulation system based on electro-myo-stimulation (EMS) technology. It is intended to be used on healthy muscles and clients, not for rehabilitation purposes.

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. MI.BO. ® MyoBoost EMS System (MB-1000, MB-400) training programs are NOT designed for injured or ailing muscles and its use on such muscles is contraindicated.

The various types of muscle work that the MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) can impose on the stimulated muscles are able to improve or facilitate muscle performance.

Device Description

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a powered muscle stimulation system based on electro-myo-stimulation (EMS) technology.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a powered muscle stimulator. It does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria in the way typically seen for AI/ML-driven medical devices.

The document is for a physical device, the "MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)", which uses electro-myo-stimulation (EMS) technology to stimulate healthy muscles. The FDA's letter is a clearance to market, not a detailed report of a performance study against specific AI/ML acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text. The questions posed relate to the evaluation of AI/ML algorithms, which is not the subject of this 510(k) clearance.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).