Cleared Traditional

K240108 - Wrap Accessory Electrodes (GMX-ABSBELT01 (FDA 510(k) Clearance)

Also includes:

GMX-ABSBELT02 GMX-WRIST01 GMX-ELBOW01 GMX-LEG01, GMX-ANKLE01, GMX-KNEE01 GMX-FOOT PAD01 GMX-GLOVES01 SHOULDER01 GMX-NCK01)

K240108 · Gymmax Technology Shenzhen Co., Ltd. · Physical Medicine device

Jun 2024

Decision

146d

Days

Class 2

Risk

K240108 is an FDA 510(k) clearance for the Wrap Accessory Electrodes (GMX-ABSBELT01. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).

Submitted by Gymmax Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 10, 2024, 146 days after receiving the submission on January 16, 2024.

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

Submission Details

510(k) Number	K240108 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 16, 2024
Decision Date	June 10, 2024
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF