Cleared Traditional

K994065 - MS-ONE, MODEL MS-1

K994065 is an FDA 510(k) clearance for MS-ONE, manufactured by Home Wellness West. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K994065 · Home Wellness West · Physical Medicine device
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Apr 2000
Decision
125d
Days
Class 2
Risk

K994065 is an FDA 510(k) clearance for the MS-ONE, MODEL MS-1. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Home Wellness West (San Diego, US). The FDA issued a Cleared decision on April 4, 2000 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Home Wellness West devices

FDA 510(k) Submission Details - K994065

510(k) Number K994065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1999
Decision Date April 04, 2000
Days to Decision 125 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 230
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K994065.
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · Rich-Mar Corp. · Aug 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · Control Solutions, Inc. · Jul 2000
HMS NEUROMUSCULAR STIMULATOR
K994062 · Home Medical Services, Inc. · Apr 2000
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
K993821 · Metron Medical Australia, Pty, Ltd. · Dec 1999
IF8000
K991241 · Dan Med, Inc. · Nov 1999
TRIO 300
K990787 · Ito Co., Ltd. · Oct 1999