Cleared Traditional

K021359 - DIGI-PRO TENS MODEL WL-2203 AND WL-2205

K021359 is an FDA 510(k) clearance for DIGI-PRO TENS MODEL WL-2203 AND WL-2205, manufactured by Well-Life Healthcare, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021359 · Well-Life Healthcare, Inc. · Neurology device
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Apr 2002
Decision
90d
Days
Class 2
Risk

K021359 is an FDA 510(k) clearance for the DIGI-PRO TENS MODEL WL-2203 AND WL-2205. 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 April 30, 2002 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K021359

510(k) Number K021359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2002
Decision Date April 30, 2002
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

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 346
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K021359.
CEFAR MEDICAL AB CEFAR PRIMO
K020803 · Cefar Medical AB · Jun 2002
ULTIMA TENS XL-A1
K020846 · Tenscare, Ltd. · May 2002
SANIDAD HEALTH-UP TENS MP-73725
K014126 · Roc Chinese-European Industrial Research Society · May 2002
TRUWAVE
K013210 · Dan Med, Inc. · Apr 2002
RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
K020180 · Woodside Biomedical, Inc. · Mar 2002
CLASSIC TENS
K020437 · Care Rehab, Inc. · Mar 2002