Cleared Traditional

ELECTRO-NERVE STIMULATOR HL (K841184) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841184 · Biomedical Life Systems, Inc. · Neurology device
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Oct 1984
Decision
198d
Days
Class 2
Risk

K841184 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR HL. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 198 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

Submission Details

510(k) Number K841184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1984
Decision Date October 04, 1984
Days to Decision 198 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 148d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K841184.
INTERCEPTOR, 662-01
K844279 · Intermedics, Inc. · Jan 1985
STIMTECH SD CLINICIAN 6090 #78-8055
K844212 · Codman & Shurtleff, Inc. · Jan 1985
STIMTECH SD PATIENT 6089 #78-8050
K844213 · Codman & Shurtleff, Inc. · Jan 1985
SD PLUS PATIENT CAT.#78-8010
K840963 · Codman & Shurtleff, Inc. · Apr 1984
SD PLUS CLINICIAN CAT# 78-8015
K840964 · Codman & Shurtleff, Inc. · Apr 1984
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · Medtronic Vascular · Aug 1983