Cleared Traditional

K905377 - ELECTRO-NERVE STIMULATOR TENS MODEL SYS...

K905377 is an FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS MODEL SYS..., manufactured by Biomedical Life Systems, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K905377 · Biomedical Life Systems, Inc. · Neurology device
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Jun 1991
Decision
186d
Days
Class 2
Risk

K905377 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (San Marcos, US). The FDA issued a Cleared decision on June 4, 1991 after a review of 186 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

FDA 510(k) Submission Details - K905377

510(k) Number K905377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1990
Decision Date June 04, 1991
Days to Decision 186 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 148d · This submission: 186d
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 162
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K905377.
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K912348 · Medical Devices, Inc. · Jun 1991
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
K905230 · Biomedical Life Systems, Inc. · Jun 1991
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A
K905570 · Biomedical Life Systems, Inc. · Jun 1991
MC II (TM), MODEL 7200S
K903161 · Medical Devices, Inc. · Mar 1991
DYNATRON 200 MICROCURRENT
K903577 · Dynatronics Corp. · Mar 1991