Cleared Traditional

K904360 - CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR

K904360 is an FDA 510(k) clearance for CHALLENGE 4010 ONE CHANNEL WIDE PULSE S..., manufactured by Maximum Performance Technologies, Mpts, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K904360 · Maximum Performance Technologies, Mpts, Inc. · Physical Medicine device
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Oct 1991
Decision
386d
Days
Class 2
Risk

K904360 is an FDA 510(k) clearance for the CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Maximum Performance Technologies, Mpts, Inc. (Washington, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Maximum Performance Technologies, Mpts, Inc. devices

FDA 510(k) Submission Details - K904360

510(k) Number K904360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date October 15, 1991
Days to Decision 386 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 115d · This submission: 386d
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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K904360.
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