Cleared Traditional

K080304 - PRO TENS

K080304 is the FDA 510(k) clearance for PRO TENS by Well-Life Healthcare Limited. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K080304 · Well-Life Healthcare Limited · Neurology device
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Jun 2008
Decision
136d
Days
Class 2
Risk

K080304 is an FDA 510(k) clearance for the PRO TENS, MODEL WL-240 RX. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (Yunghe City, Taipei County, TW). The FDA issued a Cleared decision on June 20, 2008 after a review of 136 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 Limited devices

Submission Details

510(k) Number K080304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2008
Decision Date June 20, 2008
Days to Decision 136 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
12d faster than avg
Panel avg: 148d · This submission: 136d
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 49
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K080304.
ClearUP Sinus Pain Relief
K182025 · Tivic Health Systems, Inc. · Jan 2019
BioWaveGO
K180943 · Biowave Corporation · Aug 2018
TENS device-EmeTerm, CinvStop
K172478 · Wat Medical Technology (Ningbo) Co., Ltd. · Apr 2018
VECTRA STIM MODELS 200 AND 400
K982321 · Chattanooga Group, Inc. · Feb 1999
VECTRA PRO MODELS 2 AND 4
K982324 · Chattanooga Group, Inc. · Feb 1999
INTELECT
K974497 · Chattanooga Group, Inc. · Jan 1998