Cleared Traditional

K871126 - ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C (FDA 510(k) Clearance)

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

K871126 · Biomedical Life Systems, Inc. · Neurology device
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Jun 1987
Decision
74d
Days
Class 2
Risk

K871126 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 2, 1987 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomedical Life Systems, Inc. devices

Submission Details

510(k) Number K871126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1987
Decision Date June 02, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 148d · This submission: 74d
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 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K871126.
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Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jan 2023