Cleared Traditional

K923298 - MICRO 100,200,300, & 400 TENS

K923298 is an FDA 510(k) clearance for MICRO 100, 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 99-day FDA review.

K923298 · Skylark Device Co., Ltd. · Neurology device
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Oct 1992
Decision
99d
Days
Class 2
Risk

K923298 is an FDA 510(k) clearance for the MICRO 100,200,300, & 400 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 October 13, 1992 after a review of 99 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.

View all Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K923298

510(k) Number K923298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date October 13, 1992
Days to Decision 99 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
50d faster than avg
Panel avg: 149d · This submission: 99d
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 K923298.
SD-605 SD II PROGRAM
K923935 · Skylark Device Co., Ltd. · Oct 1992
INTELECT 600MP
K920260 · Chattanooga Group, Inc. · Oct 1992
PAIN-EEZ
K922690 · International Center For Nutritional Research · Oct 1992
K-DISPERSE
K921679 · Katecho, Inc. · Oct 1992
Q-SD
K923255 · Quantitative Medicine, Inc. · Oct 1992
TEAM-MC II
K921828 · Henley Intl. · Sep 1992