Cleared Traditional

K954334 - ACUPLUS

K954334 is an FDA 510(k) clearance for ACUPLUS, manufactured by S.H.P. Intl. Pty., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K954334 · S.H.P. Intl. Pty., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
126d
Days
Class 2
Risk

K954334 is an FDA 510(k) clearance for the ACUPLUS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by S.H.P. Intl. Pty., Ltd. (Eugene, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 126 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 S.H.P. Intl. Pty., Ltd. devices

FDA 510(k) Submission Details - K954334

510(k) Number K954334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date January 22, 1996
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
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 210
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K954334.
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K934051 · Skylark Device Co., Ltd. · Jul 1994
STAT-TENS
K931079 · Skylark Device Co., Ltd. · Jun 1994