Cleared Traditional

K940954 - SYNAPTIC 3000

K940954 is an FDA 510(k) clearance for SYNAPTIC 3000, manufactured by The Synaptic Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 1207-day FDA review.

K940954 · The Synaptic Corp. · Neurology device
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Jun 1997
Decision
1207d
Days
Class 2
Risk

K940954 is an FDA 510(k) clearance for the SYNAPTIC 3000. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by The Synaptic Corp. (Aurora, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 1207 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 The Synaptic Corp. devices

FDA 510(k) Submission Details - K940954

510(k) Number K940954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1994
Decision Date June 20, 1997
Days to Decision 1207 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
1059d slower than avg
Panel avg: 148d · This submission: 1207d
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 228
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K940954.
MODEL HS-2 TENS DEVICE
K962951 · Technalithics Laboratories, Inc. · Aug 1997
RELIEFBAND TENS UNIT (MODIFICATION)
K961050 · Maven Labs, Inc. · Aug 1997
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
K965187 · Sparta Surgical Corp. · Aug 1997
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
K970429 · Apex Medical Corp. · Apr 1997
SIMPLEX TENS
K953982 · Armstrong Industries, Inc. · Apr 1997
EPIX VT
K970203 · Empi · Apr 1997