Cleared Traditional

K182871 - Mini TENS Therapy Device (FDA 510(k) Clearance)

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

K182871 · Shenzhen Jumper Medical Equipment Co., Ltd. · Neurology device
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Aug 2019
Decision
293d
Days
Class 2
Risk

K182871 is an FDA 510(k) clearance for the Mini TENS Therapy Device. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Jumper Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 1, 2019 after a review of 293 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 Jumper Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K182871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2018
Decision Date August 01, 2019
Days to Decision 293 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 148d · This submission: 293d
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 226
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K182871.
TENS/EMS device (GUSE01)
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VEINOPLUS Back
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K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 2025
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K251856 · Everyway Medical Instruments Co.,Ltd · Nov 2025