K240108

Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)

510(k) number

K240108

Device name

Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)

Applicant

Gymmax Technology Shenzhen Co., Ltd. CN

Product code

GXY — Electrode, Cutaneous

Decision date

2024-06-10

Date received

2024-01-16

Decision

Substantially Equivalent

Clearance type

Traditional

Advisory committee

Neurology