Cleared Traditional

K040849 - MENTAMOVE

K040849 is an FDA 510(k) clearance for MENTAMOVE, manufactured by Cole & Associates. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K040849 · Cole & Associates · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
183d
Days
Class 2
Risk

K040849 is an FDA 510(k) clearance for the MENTAMOVE. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Cole & Associates (Chicago, US). The FDA issued a Cleared decision on October 1, 2004 after a review of 183 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K040849

510(k) Number K040849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2004
Decision Date October 01, 2004
Days to Decision 183 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 116d · This submission: 183d
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 490
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K040849.
SMARTWAVE MS 2000
K041063 · Newwave Medical, LLC · Dec 2004
SDS-4I
K034005 · Skylark Device & Systems Co., Ltd. · Nov 2004
PMD-2000 INTERFERENTIAL STIMULATOR
K042881 · Phoenix Medical Devices, LLC · Nov 2004
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
K032954 · Danmeter A/S · Aug 2004
BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004
CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
K041146 · Control Solutions, Inc. · Jun 2004
K040849 · MENTAMOVE
Download PDF FDA Summary Cole & Associates