Cleared Traditional

Wrap Accessory Electrodes (K210383) - FDA 510(k) Clearance

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

K210383 · Hi-Dow International, Inc. · Physical Medicine device
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Nov 2021
Decision
276d
Days
Class 2
Risk

K210383 is an FDA 510(k) clearance for the Wrap Accessory Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Hi-Dow International, Inc. (Maryland Heights, US). The FDA issued a Cleared decision on November 12, 2021 after a review of 276 days - an extended review cycle.

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 Hi-Dow International, Inc. devices

Submission Details

510(k) Number K210383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2021
Decision Date November 12, 2021
Days to Decision 276 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 115d · This submission: 276d
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 Peers - GXY Electrode, Cutaneous

All 97
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K210383.
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K210448 · Shaoxing Yingtuo Healthcare Co., Ltd. · Aug 2021