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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 149d · 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 Consultant

Bill Quanqin Dai
BILL QUANQIN DAI

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 228
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K150995.
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · Andon Health Co, Ltd. · Aug 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268 · Shenzhen As-Tec Technology Co., Ltd. · Jul 2015
PulseRelief
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SmartTENS
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GEMORE OTC TENS
K150681 · Gemore Technology Co, Ltd. · May 2015
DOLPHIN NEUROSTIM OTC
K133789 · Acumed Medical , Ltd. · Mar 2015