Cleared Traditional

K003369 - LIFECARE COMPACT TENS DEVICE

K003369 is the FDA 510(k) clearance for LIFECARE COMPACT TENS DEVICE by Lifecare , Ltd.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K003369 · Lifecare , Ltd. · Neurology device
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Mar 2001
Decision
129d
Days
Class 2
Risk

K003369 is an FDA 510(k) clearance for the LIFECARE COMPACT TENS DEVICE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Lifecare , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on March 8, 2001 after a review of 129 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 Lifecare , Ltd. devices

Submission Details

510(k) Number K003369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2000
Decision Date March 08, 2001
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 148d · This submission: 129d
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 117
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K003369.
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
K020712 · Biomedical Life Systems, Inc. · Sep 2002
WINNER CM4 COMBINATION UNIT
K012848 · Rich-Mar Corp. · Oct 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · Biomedical Life Systems, Inc. · Jun 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
K990230 · Biomedical Life Systems, Inc. · Aug 1999
VECTRA STIM MODELS 200 AND 400
K982321 · Chattanooga Group, Inc. · Feb 1999
VECTRA PRO MODELS 2 AND 4
K982324 · Chattanooga Group, Inc. · Feb 1999