# K183103: EMS Belt (Model MC0485)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Yingfeng Metal & Plastic Products Co., Ltd.
- Decided: Sep 18, 2019 after 315 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
Longest line of descent: 7 generations back to K940301 (1994). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171803: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2017) Summary page 4.
- K133929: Health Expert Elctronic Stimulator, Shenzhen Osto Technology Company Limited (2014) Summary page 4.
- K143207: Revitive IX (OTC), Actegy, Ltd. (2015) Summary page 4.

## Indications for use
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K183103
Methodology: https://510kreport.com/methodology