Cleared Traditional

K041388 - COMBINATION POWERED ELECTRICAL MUSCLE S...

K041388 is an FDA 510(k) clearance for COMBINATION POWERED ELECTRICAL MUSCLE S..., 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 182-day FDA review.

K041388 · Biomedical Life Systems, Inc. · Neurology device
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Nov 2004
Decision
182d
Days
Class 2
Risk

K041388 is an FDA 510(k) clearance for the COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATO.... 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 November 23, 2004 after a review of 182 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 - K041388

510(k) Number K041388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2004
Decision Date November 23, 2004
Days to Decision 182 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
34d slower than avg
Panel avg: 148d · This submission: 182d
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 K041388.
SELECT TENS, MODEL 4600S
K061650 · Empi · Jan 2007
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K061476 · Biomedical Life Systems, Inc. · Jul 2006
MODEL BMLS03-7
K042711 · Biomedical Life Systems, Inc. · Mar 2005
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · Bio-Medical Research, Ltd. · Apr 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · Biomedical Life Systems, Inc. · Jan 2004
NEUROTECH BAXOLVE TYPE 294
K023913 · Bio-Medical Research, Ltd. · Aug 2003