Cleared Traditional

K930102 - PULSATOR 5000

K930102 is an FDA 510(k) clearance for PULSATOR 5000, manufactured by Toys House Industrial Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K930102 · Toys House Industrial Corp. · Neurology device
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Mar 1994
Decision
439d
Days
Class 2
Risk

K930102 is an FDA 510(k) clearance for the PULSATOR 5000. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Toys House Industrial Corp. (Great Neck, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 439 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 Toys House Industrial Corp. devices

FDA 510(k) Submission Details - K930102

510(k) Number K930102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1993
Decision Date March 23, 1994
Days to Decision 439 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
291d slower than avg
Panel avg: 148d · This submission: 439d
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 288
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K930102.
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K934051 · Skylark Device Co., Ltd. · Jul 1994
STAT-TENS
K931079 · Skylark Device Co., Ltd. · Jun 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935324 · Chattanooga Group, Inc. · May 1994
HOME MICROCURRENT HMC
K935132 · Medical Devices, Inc. · Mar 1994
FLEXMATE
K934619 · Medical Devices, Inc. · Feb 1994
K-STIM CLEAR
K922202 · Katecho, Inc. · May 1993