# K133965: Otc Ems Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Jun 16, 2014 after 174 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.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K143207: Revitive IX (OTC) (2015), 17 descendants of its own
- K151834: BEMER Classic Set, BEMER Pro-Set (2017), 11 descendants of its own
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (2021), 5 descendants of its own
- K203710: Storz Medical MAGNETOLITH Muscle Stimulator (2021), 4 descendants of its own
- K240234: BTL-899MS (2024), 2 descendants of its own

## Indications for use
The OTC EMS stimulator MTIOO0I is intended to stimulate healthy muscles of the lower extremity in order to temporarily increase local blood circulation and to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K133965
Methodology: https://510kreport.com/methodology