Cleared Traditional

K933577 - POWERMATIC EXAMINATION TABLE

K933577 is the FDA 510(k) clearance for POWERMATIC EXAMINATION 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 70-day FDA review.

K933577 · Medical Device Inspection Co., Inc. · Physical Medicine device
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Sep 1993
Decision
70d
Days
Class 1
Risk

K933577 is an FDA 510(k) clearance for the POWERMATIC EXAMINATION 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 September 30, 1993 after a review of 70 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 Medical Device Inspection Co., Inc. devices

Submission Details

510(k) Number K933577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date September 30, 1993
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 K933577.
POWER WORK TABLE
K933580 · 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
MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE
K932746 · Tri W-G, Inc. · Jul 1993
MODELS 642 & 643 TILT EXAM/TREATMENT TABLE
K930802 · Tri W-G, Inc. · Mar 1993
MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE
K925594 · Tri W-G, Inc. · Feb 1993