Cleared Traditional

MEDI-PLINTH (K924905) - FDA 510(k) Clearance

Class I Physical Medicine device.

K924905 · Medi-Man Rehabilitation Products, Inc. · Physical Medicine device
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Feb 1993
Decision
140d
Days
Class 1
Risk

K924905 is an FDA 510(k) clearance for the MEDI-PLINTH. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Medi-Man Rehabilitation Products, Inc. (Canada, L4w 1p4, CA). The FDA issued a Cleared decision on February 16, 1993 after a review of 140 days - within the typical 510(k) review window.

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: 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 Medi-Man Rehabilitation Products, Inc. devices

Submission Details

510(k) Number K924905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1992
Decision Date February 16, 1993
Days to Decision 140 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.