Cleared Traditional

K221992 - Electronic Pulse Stimulator

K221992 is an FDA 510(k) clearance for Electronic Pulse Stimulator, manufactured by Beijing Choice Electronic Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K221992 · Beijing Choice Electronic Technology Co., Ltd. · Neurology device
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Oct 2022
Decision
107d
Days
Class 2
Risk

K221992 is an FDA 510(k) clearance for the Electronic Pulse Stimulator. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 21, 2022 after a review of 107 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beijing Choice Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K221992

510(k) Number K221992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2022
Decision Date October 21, 2022
Days to Decision 107 days
Submission Type Traditional
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
41d faster than avg
Panel avg: 148d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

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 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K221992.
TENS and EMS Stimulation (OTC)
K230174 · Changsha Yuwen Medical Equipment Co., Ltd. · Mar 2023
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867 · Andon Health Co, Ltd. · Dec 2022
Everyway Analog OTC TENS
K222488 · Everyway Medical Instruments Co.,Ltd · Nov 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · Shenzhen Future Electronic Co., Ltd. · Sep 2022
Wireless TENS/EMS, Bruno, Aela
K220997 · Zmi Elecronics , Ltd. · Sep 2022
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
K220998 · Shenzhen Kentro Medical Electronics Co., Ltd. · Aug 2022