Cleared Traditional

K200942 - Well-Life Garment Electrodes (GM Series) (FDA 510(k) Clearance)

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

K200942 · Well-Life Healthcare Limited · Neurology device
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Jun 2021
Decision
419d
Days
Class 2
Risk

K200942 is an FDA 510(k) clearance for the Well-Life Garment Electrodes (GM Series). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (New Taipei City, TW). The FDA issued a Cleared decision on June 1, 2021 after a review of 419 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 Well-Life Healthcare Limited devices

Submission Details

510(k) Number K200942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2020
Decision Date June 01, 2021
Days to Decision 419 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 148d · This submission: 419d
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 Peers - GXY Electrode, Cutaneous

All 433
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