Cleared Traditional

CHANLLENGE 1010 PATIENT KEY PROGRAM STATION (K903149) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903149 · Maximum Performance Technologies, Mpts, Inc. · Physical Medicine device
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Nov 1990
Decision
110d
Days
Class 2
Risk

K903149 is an FDA 510(k) clearance for the CHANLLENGE 1010 PATIENT KEY PROGRAM STATION. 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 November 5, 1990 after a review of 110 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 Maximum Performance Technologies, Mpts, Inc. devices

Submission Details

510(k) Number K903149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date November 05, 1990
Days to Decision 110 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
5d faster than avg
Panel avg: 115d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 546
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