Search Results
Found 1 results
510(k) Data Aggregation
K Number
K201257Device Name
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Manufacturer
Date Cleared
2021-04-06
(330 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Arrive Systems Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1