Cleared Traditional

K905571 - ELECTRO-NERVE STIMULATOR TENS MODEL

K905571 is an FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS MODEL, 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 147-day FDA review.

K905571 · Biomedical Life Systems, Inc. · Neurology device
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May 1991
Decision
147d
Days
Class 2
Risk

K905571 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (San Marcos, US). The FDA issued a Cleared decision on May 8, 1991 after a review of 147 days - within the typical 510(k) review window.

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 - K905571

510(k) Number K905571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date May 08, 1991
Days to Decision 147 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
1d faster than avg
Panel avg: 148d · This submission: 147d
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 33
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K905571.
MULTI III
K921953 · Excel Tech. , Ltd. · Aug 1992
ISOTRON III
K921954 · Excel Tech. , Ltd. · Aug 1992
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
K921441 · Biomedical Life Systems, Inc. · May 1992
IF-II (TM), MODEL 9800
K883462 · Medical Devices, Inc. · May 1989
SYS*STIM 220
K883080 · Mettler Electronics Corp. · Apr 1989
ENDOMED 433
K870384 · Henley Intl. · Apr 1988