Cleared Abbreviated

K990230 - ELECTRO-NERVE STIMULATOR TENS

K990230 is the FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS by Biomedical Life Systems, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Abbreviated 510(k) pathway after a 206-day FDA review.

K990230 · Biomedical Life Systems, Inc. · Neurology device
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Aug 1999
Decision
206d
Days
Class 2
Risk

K990230 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS, MODEL LX. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (Vista, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 206 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Biomedical Life Systems, Inc. devices

Submission Details

510(k) Number K990230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date August 19, 1999
Days to Decision 206 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 148d · This submission: 206d
Pathway characteristics
Standards-based clearance path.

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 128
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K990230.
NT MEDITENS PLUS, TYPE 290
K014020 · Bio-Medical Research, Ltd. · Jul 2002
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K012848 · Rich-Mar Corp. · Oct 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · Biomedical Life Systems, Inc. · Jun 2001
VECTRA STIM MODELS 200 AND 400
K982321 · Chattanooga Group, Inc. · Feb 1999
VECTRA PRO MODELS 2 AND 4
K982324 · Chattanooga Group, Inc. · Feb 1999
NT2000
K972244 · Bio-Medical Research, Ltd. · Feb 1998