Cleared Traditional

K912178 - BIO TENS 601

K912178 is an FDA 510(k) clearance for BIO TENS 601, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K912178 · Skylark Device Co., Ltd. · Neurology device
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Oct 1991
Decision
162d
Days
Class 2
Risk

K912178 is an FDA 510(k) clearance for the BIO TENS 601, 606 AND 608 (3000). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, Taiwan, R.O.C., TW). The FDA issued a Cleared decision on October 25, 1991 after a review of 162 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K912178

510(k) Number K912178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date October 25, 1991
Days to Decision 162 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 148d · This submission: 162d
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 154
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K912178.
LOW BACK STRIP (OR) K-BACK
K912381 · Katecho, Inc. · Jan 1992
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K914871 · Labeltape Meditect, Inc. · Dec 1991
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
TEAM-MC
K905672 · Henley Intl. · Oct 1991
DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular · Aug 1991
SX90 (TM),MODEL 4800S
K912348 · Medical Devices, Inc. · Jun 1991