Cleared Traditional

K923935 - SD-605 SD II PROGRAM

K923935 is an FDA 510(k) clearance for SD-605 SD II PROGRAM, 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 71-day FDA review.

K923935 · Skylark Device Co., Ltd. · Neurology device
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Oct 1992
Decision
71d
Days
Class 2
Risk

K923935 is an FDA 510(k) clearance for the SD-605 SD II PROGRAM. 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 15, 1992 after a review of 71 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K923935

510(k) Number K923935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date October 15, 1992
Days to Decision 71 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
77d faster than avg
Panel avg: 148d · This submission: 71d
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 K923935.
FLEXMATE
K934619 · Medical Devices, Inc. · Feb 1994
K-STIM CLEAR
K922202 · Katecho, Inc. · May 1993
THERA PULSE A ELECTRO NERVE STIMULATOR
K925686 · Biomedical Life Systems, Inc. · Mar 1993
INTELECT 600MP
K920260 · Chattanooga Group, Inc. · Oct 1992
K-DISPERSE
K921679 · Katecho, Inc. · Oct 1992
TEAM-MC II
K921828 · Henley Intl. · Sep 1992