Cleared Traditional

K841145 - TILT TABLE 53

K841145 is the FDA 510(k) clearance for TILT TABLE 53 by S & W Enterprises, Inc.. It is a Class 1 Physical Medicine device (product code INQ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K841145 · S & W Enterprises, Inc. · Physical Medicine device
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Apr 1984
Decision
28d
Days
Class 1
Risk

K841145 is an FDA 510(k) clearance for the TILT TABLE 53. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by S & W Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 28 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 S & W Enterprises, Inc. devices

Submission Details

510(k) Number K841145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1984
Decision Date April 13, 1984
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
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 16
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K841145.
HI-LO TILT TABLE 625
K850377 · Tri W-G, Inc. · May 1985
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO
K844712 · Tri W-G, Inc. · Mar 1985
MOBILIZATIOIN TABLE
K841594 · Chattanooga Group, Inc. · May 1984
TABLE, MODELS 610,611 & 612
K834103 · Tri W-G, Inc. · Jan 1984
CHIROPRACTIC ADJUSTING TABLE MODEL 646
K822221 · Tri W-G, Inc. · Aug 1982