# K213197: MyOnyx System

- Pathway: 510(k) (Traditional)
- Applicant: Thought Technology, Ltd.
- Decided: Jun 17, 2022 after 261 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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: 4 generations back to K984142 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171978: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10, Shenzhen Dongdixin Technology Co., Ltd. (2017) Summary page 4.

## Indications for use
The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.

Source page: https://510kreport.com/device/K213197
Methodology: https://510kreport.com/methodology