Cleared Traditional

K885276 - MODEL L-2000 & L-500 CHIROPRACTIC TABLES

K885276 is an FDA 510(k) clearance for MODEL L-2000 & L-500 CHIROPRACTIC TABLES, manufactured by Lesarn Mfg., Ltd.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K885276 · Lesarn Mfg., Ltd. · Physical Medicine device
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Apr 1989
Decision
124d
Days
Class 1
Risk

K885276 is an FDA 510(k) clearance for the MODEL L-2000 & L-500 CHIROPRACTIC TABLES. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Lesarn Mfg., Ltd. (Oakville, Ont, CA). The FDA issued a Cleared decision on April 26, 1989 after a review of 124 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 Lesarn Mfg., Ltd. devices

FDA 510(k) Submission Details - K885276

510(k) Number K885276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date April 26, 1989
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
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 49
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K885276.
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
HLE-1000 HIGH/LOW TREATMENT TABLE
K883659 · Rich-Mar Corp. · Oct 1988
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