Cleared Traditional

K150995 - Electronic Pulse Stimulator

K150995 is an FDA 510(k) clearance for Electronic Pulse Stimulator, manufactured by Shenzhen Jingkehui Electronic Co.., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K150995 · Shenzhen Jingkehui Electronic Co.., Ltd. · Neurology device
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Jul 2015
Decision
82d
Days
Class 2
Risk

K150995 is an FDA 510(k) clearance for the Electronic Pulse Stimulator. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Jingkehui Electronic Co.., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 6, 2015 after a review of 82 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 Jingkehui Electronic Co.., Ltd. devices

FDA 510(k) Submission Details - K150995

510(k) Number K150995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date July 06, 2015
Days to Decision 82 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
66d faster than avg
Panel avg: 148d · This submission: 82d
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 Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 145
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K150995.
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