Cleared Traditional

K232995 - Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005 (FDA 510(k) Clearance)

Also includes:
Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004 Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011 Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006 Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007 Electrothe

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232995 · Shenzhen Roundwhale Technology Co. , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
111d
Days
Class 2
Risk

K232995 is an FDA 510(k) clearance for the Neurological Therapy Devices - Accessories: Electrotherapy device Electrode b.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Shenzhen Roundwhale Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 11, 2024 after a review of 111 days - within the typical 510(k) review window.

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.

View all Shenzhen Roundwhale Technology Co. , Ltd. devices

Submission Details

510(k) Number K232995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date January 11, 2024
Days to Decision 111 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
37d faster than avg
Panel avg: 148d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - GXY Electrode, Cutaneous

All 433
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K232995.
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