Cleared Traditional

K003258 - MS-ONE, MODEL MS-1

K003258 is an FDA 510(k) clearance for MS-ONE, manufactured by Home Wellness West. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K003258 · Home Wellness West · Neurology device
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Jan 2001
Decision
86d
Days
Class 2
Risk

K003258 is an FDA 510(k) clearance for the MS-ONE, MODEL MS-1. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Home Wellness West (San Diego, US). The FDA issued a Cleared decision on January 12, 2001 after a review of 86 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.

View all Home Wellness West devices

FDA 510(k) Submission Details - K003258

510(k) Number K003258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date January 12, 2001
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 K003258.
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · Biomedical Life Systems, Inc. · Jun 2001
ANALGESIC PULSER, MODEL AP-439
K993229 · Johari Electro-Tech Co. · Feb 2001
STIMATE N601 TENS
K003487 · Everyway Medical Instruments Co.,Ltd · Jan 2001
MEDISANA DIGITAL TENS
K994265 · Fuji Dynamics Limited · Jul 2000
FDTENS 2010
K994266 · Fuji Dynamics Limited · Jul 2000
ENDOR 2000
K984376 · T.C. Medical, Inc. · Jun 2000