Cleared Traditional

K041092 - FAST START TENS, MODEL FS 3001

K041092 is an FDA 510(k) clearance for FAST START TENS, manufactured by Vision Quest Industries, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K041092 · Vision Quest Industries, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
66d
Days
Class 2
Risk

K041092 is an FDA 510(k) clearance for the FAST START TENS, MODEL FS 3001. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Vision Quest Industries, Inc. (Irvine, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 66 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.

FDA 510(k) Submission Details - K041092

510(k) Number K041092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date July 01, 2004
Days to Decision 66 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
83d faster than avg
Panel avg: 149d · This submission: 66d
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 385
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K041092.
MANTRA TENS MODEL NT3
K041520 · Mantra Intl. (Hk) , Ltd. · Sep 2004
BODY CLOCK STIMPLUS AND STIMPLUS PRO
K041359 · Body Clock Health Care, Ltd. · Aug 2004
FENZIAN TREATMENT SYSTEM
K041575 · Eumedic Limited · Jul 2004
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
K040512 · Well-Life Healthcare, Inc. · May 2004
L-TENS
K041164 · Fuji Dynamics Limited · May 2004
MODEL GST-1
K040193 · Medical Equipment Device Specialists · Apr 2004
K041092 · FAST START TENS, MODEL FS 3001
Download PDF FDA Summary Vision Quest Industri…