Cleared Traditional

K946299 - PGS123 AND HVS-123

K946299 is an FDA 510(k) clearance for PGS123 AND HVS-123, 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 181-day FDA review.

K946299 · Skylark Device Co., Ltd. · Neurology device
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Jun 1995
Decision
181d
Days
Class 2
Risk

K946299 is an FDA 510(k) clearance for the PGS123 AND HVS-123. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on June 26, 1995 after a review of 181 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 - K946299

510(k) Number K946299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1994
Decision Date June 26, 1995
Days to Decision 181 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
33d slower than avg
Panel avg: 148d · This submission: 181d
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 153
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K946299.
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