Cleared Traditional

K925686 - THERA PULSE A ELECTRO NERVE STIMULATOR

K925686 is an FDA 510(k) clearance for THERA PULSE A ELECTRO NERVE STIMULATOR, 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 126-day FDA review.

K925686 · Biomedical Life Systems, Inc. · Neurology device
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Mar 1993
Decision
126d
Days
Class 2
Risk

K925686 is an FDA 510(k) clearance for the THERA PULSE A ELECTRO NERVE STIMULATOR. 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 March 18, 1993 after a review of 126 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.

FDA 510(k) Submission Details - K925686

510(k) Number K925686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date March 18, 1993
Days to Decision 126 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
23d faster than avg
Panel avg: 149d · This submission: 126d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K925686.
STAODYN MAXIMA III
K930865 · Staodyne, Inc. · May 1993
COMFORTRON
K925821 · M. D. Supply, Inc. · May 1993
TENS PRO 900
K915663 · Acuhealth (Usa) Pty. , Ltd. · Apr 1993
MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS
K925898 · Staodyne, Inc. · Jan 1993
SD-602 SD MODE 11, SD-603 SD MOD 111
K925729 · Skylark Device Co., Ltd. · Jan 1993
TENS MODEL 240Z
K920266 · Oms Medical Supplies, Inc. · Dec 1992
K925686 · THERA PULSE A ELECTRO NERVE STIMULATOR
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