Cleared Traditional

K841184 - ELECTRO-NERVE STIMULATOR HL

K841184 is an FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR HL, 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 198-day FDA review.

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

FDA 510(k) Submission Details - K841184

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
Combination Product No
PCCP Authorized No
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.

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 K841184.
ELECTRO-NERVE STIMULATOR B5/SK700B
K844076 · Biomedical Life Systems, 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
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K842812 · Mentor Corp. · Aug 1984
NEURO PULSE
K841400 · Parker Laboratories, Inc. · Jun 1984
SD PLUS PATIENT CAT.#78-8010
K840963 · Codman & Shurtleff, Inc. · Apr 1984