Cleared Traditional

K152128 - 2-in-1 Abdominal Muscle Training & Back Pain Relief System

K152128 is an FDA 510(k) clearance for 2-in-1 Abdominal Muscle Training & Back..., manufactured by Tohkai Precision Electrical Manufactory (Shenzhen) Limited. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K152128 · Tohkai Precision Electrical Manufactory (Shenzhen) Limited · Neurology device
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Dec 2015
Decision
145d
Days
Class 2
Risk

K152128 is an FDA 510(k) clearance for the 2-in-1 Abdominal Muscle Training & Back Pain Relief System. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Tohkai Precision Electrical Manufactory (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2015 after a review of 145 days - within the typical 510(k) review window.

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 Tohkai Precision Electrical Manufactory (Shenzhen) Limited devices

FDA 510(k) Submission Details - K152128

510(k) Number K152128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2015
Decision Date December 23, 2015
Days to Decision 145 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 149d · This submission: 145d
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

Guangzhou GLOMED Biological Technology Co., Ltd.
CECILIA CENG

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
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