Cleared Traditional

K220005 - TENS & PMS Unit

K220005 is an FDA 510(k) clearance for TENS & PMS Unit, manufactured by Shenzhen Yuehua Xinsen Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K220005 · Shenzhen Yuehua Xinsen Technology Co., Ltd. · Neurology device
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Apr 2022
Decision
87d
Days
Class 2
Risk

K220005 is an FDA 510(k) clearance for the TENS & PMS Unit. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Yuehua Xinsen Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 1, 2022 after a review of 87 days - a notably fast clearance 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: 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 Shenzhen Yuehua Xinsen Technology Co., Ltd. devices

FDA 510(k) Submission Details - K220005

510(k) Number K220005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2022
Decision Date April 01, 2022
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
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

Guangdong Jianda Medical Technology Co., Ltd.
Iris Fung

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 K220005.
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
K220152 · Hong Qiangxing (Shenzhen) Electronics Limited · Apr 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377 · Ningbo Medkinetic Medical Device Co., Ltd. · Apr 2022
TENS and EMS Stimulation (OTC)
K212184 · Changsha Yuwen Medical Equipment Co., Ltd. · Apr 2022
TENS & EMS DEVICE (Model: FM-B2403A)
K213741 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · Mar 2022
TENS & EMS Device
K213835 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · Mar 2022
Well-Life TENS/EMS/Heating Stimulator
K213091 · Well-Life Healthcare Limited · Feb 2022