Cleared Traditional

TREATMENT TABLES, ELECTRICALLY ACTIVATED (K932412) - FDA 510(k) Clearance

Class I Physical Medicine device.

K932412 · Med Mart, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
111d
Days
Class 1
Risk

K932412 is an FDA 510(k) clearance for the TREATMENT TABLES, ELECTRICALLY ACTIVATED. 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 July 21, 1993 after a review of 111 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 Med Mart, Inc. devices

Submission Details

510(k) Number K932412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date July 21, 1993
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
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.