Cleared Traditional

TENS and EMS Stimulation (OTC) (K230164) - FDA 510(k) Clearance

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

K230164 · Changsha Yuwen Medical Equipment Co., Ltd. · Physical Medicine device
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Apr 2023
Decision
80d
Days
Class 2
Risk

K230164 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 April 10, 2023 after a review of 80 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 K230164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2023
Decision Date April 10, 2023
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K230164.
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
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
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867 · Andon Health Co, Ltd. · Dec 2022