Cleared Traditional

K931079 - STAT-TENS

K931079 is an FDA 510(k) clearance for STAT-TENS, 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 463-day FDA review.

K931079 · Skylark Device Co., Ltd. · Neurology device
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Jun 1994
Decision
463d
Days
Class 2
Risk

K931079 is an FDA 510(k) clearance for the STAT-TENS. 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 June 9, 1994 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K931079

510(k) Number K931079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date June 09, 1994
Days to Decision 463 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
314d slower than avg
Panel avg: 149d · This submission: 463d
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 378
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K931079.
MEDI-STIM, MODIFICATION
K933237 · Mid-Canada Medical · Sep 1994
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K934051 · Skylark Device Co., Ltd. · Jul 1994
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K932897 · Nemectron GmbH · Jul 1994
TENS-IT
K933368 · Electro Med Supply, Inc. · Jun 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935324 · Chattanooga Group, Inc. · May 1994
NEURON II AND MICROTENS
K935395 · Datran Corp. · Apr 1994