Cleared Traditional

K040007 - INTERFERENTIAL STIMULATOR, MODEL BMLS02-6

K040007 is an FDA 510(k) clearance for INTERFERENTIAL STIMULATOR, manufactured by Biomedical Life Systems, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K040007 · Biomedical Life Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
187d
Days
Class 2
Risk

K040007 is an FDA 510(k) clearance for the INTERFERENTIAL STIMULATOR, MODEL BMLS02-6. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (Vista, US). The FDA issued a Cleared decision on July 7, 2004 after a review of 187 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 - K040007

510(k) Number K040007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2004
Decision Date July 07, 2004
Days to Decision 187 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
38d slower than avg
Panel avg: 149d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
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 - LIH Interferential Current Therapy

All 60
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K040007.
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
K052289 · Biowave Corporation · Dec 2005
INF 4160, MODEL D-FJ27F
K043407 · Fuji Dynamics Limited · Feb 2005
INFINITY ELECTROTHERAPY SYSTEM
K042057 · Empi · Dec 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
K032719 · Gemore Technology Co, Ltd. · Dec 2003
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K033358 · Surgitech, Inc. · Nov 2003