Cleared Traditional

K915210 - ELECTRO-NERVE STIMULATOR TENS MODEL MIC...

K915210 is the FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS MODEL MIC... by Biomedical Life Systems, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K915210 · Biomedical Life Systems, Inc. · Neurology device
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May 1992
Decision
168d
Days
Class 2
Risk

K915210 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A. 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 May 4, 1992 after a review of 168 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 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 Biomedical Life Systems, Inc. devices

Submission Details

510(k) Number K915210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date May 04, 1992
Days to Decision 168 days
Submission Type Traditional
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
20d slower than avg
Panel avg: 148d · This submission: 168d
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 128
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K915210.
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MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
TEAM-MC
K905672 · Henley Intl. · Oct 1991
DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular · Aug 1991