Cleared Traditional

K883659 - HLE-1000 HIGH/LOW TREATMENT TABLE

K883659 is the FDA 510(k) clearance for HLE-1000 HIGH/LOW TREATMENT TABLE by Rich-Mar Corp.. It is a Class 1 Physical Medicine device (product code INQ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K883659 · Rich-Mar Corp. · Physical Medicine device
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Oct 1988
Decision
48d
Days
Class 1
Risk

K883659 is an FDA 510(k) clearance for the HLE-1000 HIGH/LOW TREATMENT TABLE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on October 13, 1988 after a review of 48 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 Rich-Mar Corp. devices

Submission Details

510(k) Number K883659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1988
Decision Date October 13, 1988
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
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 K883659.
MODEL 600 MEDICAL TREATMENT TABLE
K923325 · Tri W-G, Inc. · Jul 1992
MAT TABLE, 8100 SERIES MAT PLATFORM
K920585 · Tri W-G, Inc. · Apr 1992
POWER PODIATRY CHAIR/TABLE #414, #416 & #417
K894017 · Midmark Corp. · Jul 1989
R1698,R1701,R1215,R1700 & R860 POWERED TABLES
K861352 · Tri W-G, Inc. · May 1986
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