Wrap Accessory Electrodes (GMX-ABSBELT01 +8 more— 510(k) K240108
Substantially EquivalentGymmax Technology Shenzhen Co., Ltd.
FDA 510(k) clearance K240108 for Wrap Accessory Electrodes (GMX-ABSBELT01 +8 more, Substantially Equivalent on 2024-06-10. Applicant: Gymmax Technology Shenzhen Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.