Cleared Traditional

K152648 - Ennova Self-adhesive Electrode

K152648 is an FDA 510(k) clearance for Ennova Self-adhesive Electrode, manufactured by Suzhou Ennova Electronics Technology Co.,Ltd. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K152648 · Suzhou Ennova Electronics Technology Co.,Ltd · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
155d
Days
Class 2
Risk

K152648 is an FDA 510(k) clearance for the Ennova Self-adhesive Electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Suzhou Ennova Electronics Technology Co.,Ltd (Suzhou, CN). The FDA issued a Cleared decision on February 18, 2016 after a review of 155 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

FDA 510(k) Submission Details - K152648

510(k) Number K152648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2015
Decision Date February 18, 2016
Days to Decision 155 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
6d slower than avg
Panel avg: 149d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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

Shanghai CV Technology Co., Ltd.
DORIS DONG

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 - GXY Electrode, Cutaneous

All 358
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K152648.
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