Cleared Traditional

K033455 - ELECTRO-NERVE STIMULATOR TENS

K033455 is an FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS, 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 77-day FDA review.

K033455 · Biomedical Life Systems, Inc. · Neurology device
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Jan 2004
Decision
77d
Days
Class 2
Risk

K033455 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5. 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 January 15, 2004 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomedical Life Systems, Inc. devices

FDA 510(k) Submission Details - K033455

510(k) Number K033455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date January 15, 2004
Days to Decision 77 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
71d faster than avg
Panel avg: 148d · This submission: 77d
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 K033455.
MODEL BMLS03-7
K042711 · Biomedical Life Systems, Inc. · Mar 2005
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
K041388 · Biomedical Life Systems, Inc. · Nov 2004
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · Bio-Medical Research, Ltd. · Apr 2004
NEUROTECH BAXOLVE TYPE 294
K023913 · Bio-Medical Research, Ltd. · Aug 2003
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K022841 · Biomedical Life Systems, Inc. · Nov 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · Biomedical Life Systems, Inc. · Nov 2002