Cleared Traditional

K933581 - POWERMATIC TREATMENT TABLE

K933581 is an FDA 510(k) clearance for POWERMATIC TREATMENT TABLE, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K933581 · Medical Device Inspection Co., Inc. · Physical Medicine device
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Nov 1993
Decision
106d
Days
Class 1
Risk

K933581 is an FDA 510(k) clearance for the POWERMATIC TREATMENT 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

FDA 510(k) Submission Details - K933581

510(k) Number K933581 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.

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 48
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K933581.
TREATMENT TABLE MODIFICATION
K936303 · Tri W-G, Inc. · Mar 1994
POWERMATIC MAT PLATFORM
K933578 · Medical Device Inspection Co., Inc. · Nov 1993
POWER WORK TABLE
K933580 · 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
MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE
K932746 · Tri W-G, Inc. · Jul 1993