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Neurological Therapy Devices - Accessories: Electrotherapy device Electrode bel…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232995

by Shenzhen Roundwhale Technology Co. Ltd.

Identifiers

510(k) Number
K232995 FDA 510(k)
FDA Product Code
GXY FDA 510(k)
Models / Variants
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005 FDA 510(k)
Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004 FDA 510(k)
Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011 FDA 510(k)
Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006 FDA 510(k)
Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007 FDA 510(k)
Electrothe FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode bel… by Shenzhen Roundwhale Technology Co. Ltd. — Class II — FDA_510K — listed in…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Roundwhale Technology Co. Ltd.
FDA Applicant
Shenzhen Roundwhale Technology Co. , Ltd.

Sources (1)

  • FDA 510(k) K232995 24 fields · synced Jun 18, 2026