Cleared Traditional

K230163 - TENS and EMS Stimulation (OTC) (FDA 510(k) Clearance)

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

K230163 · Changsha Yuwen Medical Equipment Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
59d
Days
Class 2
Risk

K230163 is an FDA 510(k) clearance for the TENS and EMS Stimulation (OTC). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Changsha Yuwen Medical Equipment Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on March 20, 2023 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Changsha Yuwen Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K230163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2023
Decision Date March 20, 2023
Days to Decision 59 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
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 Physical Medicine devices follow this clearance model.

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

All 226
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K230163.
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