OGYILI TENS/NMES Stimulator— 510(k) K201431

Name: FDA 510(k) clearance K201431
Creator: U.S. Food and Drug Administration
Published: 2020-11-09

Substantially Equivalent

Gongguan Tutamen Metalwork Co., Ltd.

FDA 510(k) clearance K201431 for OGYILI TENS/NMES Stimulator, Substantially Equivalent on 2020-11-09. Applicant: Gongguan Tutamen Metalwork Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gongguan Tutamen Metalwork Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2020-06-01
Decision date: 2020-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

view all

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.