# K201257: MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

- Pathway: 510(k) (Traditional)
- Applicant: Arrive Systems, Inc.
- Decided: Apr 6, 2021 after 330 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MI.BO. 9 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. 9 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. 9 MyoBoost EMS System (MB-1000, MB-600, 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. 9 MyoBoost EMS System (MB-1000, MB-600, MB-400) can impose on the stimulated muscles are able to improve or facilitate muscle performance.

Source page: https://510kreport.com/device/K201257
Methodology: https://510kreport.com/methodology