Cleared Traditional

K240108 - Wrap Accessory Electrodes (GMX-ABSBELT01

Also marketed or referenced as:
GMX-ABSBELT02 GMX-WRIST01 GMX-ELBOW01 GMX-LEG01, GMX-ANKLE01, GMX-KNEE01 GMX-FOOT PAD01 GMX-GLOVES01 SHOULDER01 GMX-NCK01)

K240108 is an FDA 510(k) clearance for Wrap Accessory Electrodes (GMX-ABSBELT01, manufactured by Gymmax Technology Shenzhen Co., Ltd.. The device is a Class 2 Physical Medicine device with product code GXY cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K240108 · Gymmax Technology Shenzhen Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
146d
Days
Class 2
Risk

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

Submitted by Gymmax Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 10, 2024 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.1320 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Gymmax Technology Shenzhen Co., Ltd. devices

FDA 510(k) Submission Details - K240108

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 115d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Imd Medical & Drug Technology Service Institutions
Salon Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 187
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