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
K232995 · Shenzhen Roundwhale Technology Co. , Ltd. · Neurology device
Jan 2024
Decision
111d
Days
Class 2
Risk

K232995 is an FDA 510(k) clearance for the Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).

Submitted by Shenzhen Roundwhale Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 11, 2024, 111 days after receiving the submission on September 22, 2023.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.

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

Device Classification

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