Cleared Traditional

K140333 - ASCEND

K140333 is an FDA 510(k) clearance for ASCEND, manufactured by Neurometrix, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K140333 · Neurometrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
143d
Days
Class 2
Risk

K140333 is an FDA 510(k) clearance for the ASCEND. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Neurometrix, Inc. (Waltham, US). The FDA issued a Cleared decision on July 3, 2014 after a review of 143 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 Neurometrix, Inc. devices

FDA 510(k) Submission Details - K140333

510(k) Number K140333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2014
Decision Date July 03, 2014
Days to Decision 143 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 148d · This submission: 143d
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 160
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K140333.
Transcutaneous Electrical Nerve Stimulators (TENS)
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K141978 · Omron Healthcare, Inc. · Dec 2014
OTC COMBO TENS/EMS SYSTEM
K141299 · Well-Life Healthcare Limited · Nov 2014
OTC PATCH
K133723 · Well-Life Healthcare Limited · Jan 2014
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802 · Shenzhen Dongdixin Technology Co., Ltd. · Sep 2013
MINI PATCH
K121353 · Well-Life Healthcare Limited · Sep 2012