Cleared Abbreviated

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)

K222867 · Andon Health Co, Ltd. · Neurology
Dec 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K222867 is an FDA 510(k) clearance for the AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 21, 2022, 90 days after receiving the submission on September 22, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K222867 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2022
Decision Date December 21, 2022
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles

Similar Devices — NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 226
TENS/EMS device (GUSE01)
K253896 · Globalcare Medical Technology Co., Ltd. · Mar 2026
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · Shenzhen Jiantuo Electronics Co., Ltd. · Dec 2025
VEINOPLUS Back
K251958 · Dynapulse Medical · Dec 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · Hong Qiangxing (Shenzhen) Electronics Limited · Dec 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
K251856 · Everyway Medical Instruments Co.,Ltd · Nov 2025

More from Andon Health Co, Ltd.

View all
iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr
K251113 · DXN · Aug 2025
iHealth? Early Pregnancy Test; iHealth? Early Pregnancy Test Strip
K241394 · LCX · Dec 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
K234041 · DXN · Apr 2024
Arm Blood Pressure Monitor
K222869 · DXN · Feb 2023
iHealth infrared Ear thermometer PT5
K212598 · FLL · Jan 2022