Cleared Traditional

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) (K221199) - FDA 510(k) Clearance

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

K221199 · Green Island International Tcm Group Limited · Neurology device
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Dec 2023
Decision
602d
Days
Class 2
Risk

K221199 is an FDA 510(k) clearance for the Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, .... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Green Island International Tcm Group Limited (Hongkong, CN). The FDA issued a Cleared decision on December 19, 2023 after a review of 602 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Green Island International Tcm Group Limited devices

Submission Details

510(k) Number K221199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2022
Decision Date December 19, 2023
Days to Decision 602 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
454d slower than avg
Panel avg: 148d · This submission: 602d
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 Neurology devices follow this clearance model.

Regulatory Consultant

Guangzhou GLOMED Biological Technology Co., Ltd.
Cassie Lee

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 97
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