Cleared Traditional

K230443 - TENS & EMS Device (LY-ET-01

K230443 is an FDA 510(k) clearance for TENS & EMS Device (LY-ET-01, manufactured by Jiangxi Royall Smart Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K230443 · Jiangxi Royall Smart Technology Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
May 2023
Decision
90d
Days
Class 2
Risk

K230443 is an FDA 510(k) clearance for the TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Jiangxi Royall Smart Technology Co., Ltd. (Ganzhou, CN). The FDA issued a Cleared decision on May 22, 2023 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 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 Jiangxi Royall Smart Technology Co., Ltd. devices

FDA 510(k) Submission Details - K230443

510(k) Number K230443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date May 22, 2023
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 Consultant

Share Info (Guangzhou) Medical Consultant , Ltd.
Cassie Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 157
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K230443.
Heating Tens, FT-615
K232675 · Hivox Biotek, Inc. · Oct 2023
Unicare (K-UNICARE-USA)
K231053 · Tenscare, Ltd. · Aug 2023
Nu-beca Transcutaneous Electrical Nerve Stimulation
K223151 · Nu-Beca & Maxcellent Co. · Jul 2023
HEATING TENS/EMS, FT-810R
K223308 · Hivox Biotek, Inc. · May 2023
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 · Shenzhen Kentro Medical Electronics Co., Ltd. · May 2023
Tens & Ems Device
K223825 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · May 2023