# K201431: OGYILI TENS/NMES Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Gongguan Tutamen Metalwork Co., Ltd.
- Decided: Nov 9, 2020 after 161 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- 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 K912178 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193275: Nerve and Muscle Stimulator, Shenzhen Xft Medical Limited (2020) Summary page 4.

## Indications for use
TENS function of the device is indicated for the following use: Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain NMES function of the device is indicated for the following use: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis • Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K201431
Methodology: https://510kreport.com/methodology