Cleared Traditional

K830849 - OB TILT

K830849 is an FDA 510(k) clearance for OB TILT, manufactured by Lic-Orthion. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K830849 · Lic-Orthion · Physical Medicine device
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Apr 1983
Decision
19d
Days
Class 1
Risk

K830849 is an FDA 510(k) clearance for the OB TILT. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Lic-Orthion (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 19 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 Lic-Orthion devices

FDA 510(k) Submission Details - K830849

510(k) Number K830849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1983
Decision Date April 05, 1983
Days to Decision 19 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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 K830849.
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
SESAM TREATMENT TABLE
K830855 · Lic-Orthion · Apr 1983
CHIROPRACTIC ADJUSTING TABLE MODEL 646
K822221 · Tri W-G, Inc. · Aug 1982