Cleared Traditional

Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 (K222870) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222870 · Shenzhen Kentro Medical Electronics Co., Ltd. · Neurology device
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May 2023
Decision
230d
Days
Class 2
Risk

K222870 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-40.... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Kentro Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 10, 2023 after a review of 230 days - an extended review cycle.

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 Shenzhen Kentro Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K222870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2022
Decision Date May 10, 2023
Days to Decision 230 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 148d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K222870.
Nu-beca Transcutaneous Electrical Nerve Stimulation
K223151 · Nu-Beca & Maxcellent Co. · Jul 2023
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
K230443 · Jiangxi Royall Smart Technology Co., Ltd. · May 2023
HEATING TENS/EMS, FT-810R
K223308 · Hivox Biotek, Inc. · May 2023
Tens & Ems Device
K223825 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · May 2023
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
K223428 · Shenzhen Leqing Medical Instrument Co., Ltd. · May 2023
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
K230829 · Chongqing Rob Linka Science and Technology Co., Ltd. · Apr 2023