# K183454: Tyece OTC EMS System

- Pathway: 510(k) (Traditional)
- Applicant: Tyece, Ltd.
- Decided: Feb 26, 2019 after 75 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
The Tyece OTC EMS System, Model EM37 is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Source page: https://510kreport.com/device/K183454
Methodology: https://510kreport.com/methodology