Cleared Traditional

K940131 - TABLE MAT MORTORIZED/ELECTRIC

K940131 is an FDA 510(k) clearance for TABLE MAT MORTORIZED/ELECTRIC, manufactured by Med Mart, Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K940131 · Med Mart, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
53d
Days
Class 1
Risk

K940131 is an FDA 510(k) clearance for the TABLE MAT MORTORIZED/ELECTRIC. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Med Mart, Inc. (Valley City, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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: 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 Med Mart, Inc. devices

FDA 510(k) Submission Details - K940131

510(k) Number K940131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date February 25, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - INQ Table, Powered

All 49
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K940131.
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