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)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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
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.

Device Classification

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.

Regulatory Peers - GXY Electrode, Cutaneous

All 433
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