Cleared Traditional

THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) (K020020) - FDA 510(k) Clearance

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

K020020 · Well-Life Healthcare, Inc. · Neurology device
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Dec 2002
Decision
361d
Days
Class 2
Risk

K020020 is an FDA 510(k) clearance for the THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), TH.... Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Well-Life Healthcare, Inc. (Taichung, R.O.C., TW). The FDA issued a Cleared decision on December 30, 2002 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Well-Life Healthcare, Inc. devices

Submission Details

510(k) Number K020020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2002
Decision Date December 30, 2002
Days to Decision 361 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 148d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 605
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