Cleared Abbreviated

K222867 - AD-2126 Transcutaneous Electrical Nerve...

K222867 is the FDA 510(k) clearance for AD-2126 Transcutaneous Electrical Nerve... by Andon Health Co, Ltd.. It is a Class 2 Neurology device (product code NUH) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K222867 · Andon Health Co, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
90d
Days
Class 2
Risk

K222867 is an FDA 510(k) clearance for the AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 21, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K222867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 140
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K222867.
TENS and EMS Stimulation (OTC)
K230164 · Changsha Yuwen Medical Equipment Co., Ltd. · Apr 2023
TENS and EMS Stimulation (OTC)
K230163 · Changsha Yuwen Medical Equipment Co., Ltd. · Mar 2023
TENS and EMS Stimulation (OTC)
K230174 · Changsha Yuwen Medical Equipment Co., Ltd. · Mar 2023
Everyway Analog OTC TENS
K222488 · Everyway Medical Instruments Co.,Ltd · Nov 2022
Electronic Pulse Stimulator
K221992 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · Shenzhen Future Electronic Co., Ltd. · Sep 2022