Cleared Traditional

K933580 - POWER WORK TABLE

K933580 is the FDA 510(k) clearance for POWER WORK TABLE by Medical Device Inspection Co., Inc.. It is a Class 1 Physical Medicine device (product code INQ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K933580 · Medical Device Inspection Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
106d
Days
Class 1
Risk

K933580 is an FDA 510(k) clearance for the POWER WORK TABLE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 106 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 Medical Device Inspection Co., Inc. devices

Submission Details

510(k) Number K933580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date November 05, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
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.

Regulatory Peers - INQ Table, Powered

All 20
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K933580.
MODEL 747 AND 747-30 EXAM/TREATMENT TABLE
K941720 · Tri W-G, Inc. · May 1994
TREATMENT TABLE MODIFICATION
K936303 · Tri W-G, Inc. · Mar 1994
POWERMATIC MAT PLATFORM
K933578 · Medical Device Inspection Co., Inc. · Nov 1993
POWERMATIC TREATMENT TABLE
K933581 · Medical Device Inspection Co., Inc. · Nov 1993
HI-LO TREATMENT TABLES
K933119 · Tri W-G, Inc. · Oct 1993
POWERMATIC EXAMINATION TABLE
K933577 · Medical Device Inspection Co., Inc. · Sep 1993