Cleared Traditional

K933000 - RECLINING GERI CHAIRS W/CASTERS & LAP TRAY

K933000 is an FDA 510(k) clearance for RECLINING GERI CHAIRS W/CASTERS & LAP TRAY, manufactured by Winco, Inc.. The device is a Class 1 Physical Medicine device with product code INM cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K933000 · Winco, Inc. · Physical Medicine device
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Sep 1993
Decision
104d
Days
Class 1
Risk

K933000 is an FDA 510(k) clearance for the RECLINING GERI CHAIRS W/CASTERS & LAP TRAY. Classified as Chair, With Casters (product code INM), Class I - General Controls.

Submitted by Winco, Inc. (Ocala, US). The FDA issued a Cleared decision on September 30, 1993 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3100 - 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.

FDA 510(k) Submission Details - K933000

510(k) Number K933000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1993
Decision Date September 30, 1993
Days to Decision 104 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
12d faster than avg
Panel avg: 116d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

INM Device Classification - Class 1, General Controls

Product Code INM Chair, With Casters
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3100
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 - INM Chair, With Casters

All 32
Devices cleared under the same product code (INM) and FDA review panel - the closest regulatory comparables to K933000.
NISSIN PEDIATRIC SERIES WHEELCHAIR
K063521 · Nissin Medical, Inc. · Feb 2007
STRYKER 5050 STRECHAIR
K941738 · Stryker Medical · May 1994
CAREMOR CLINER
K941569 · Winco, Inc. · Apr 1994
BENCHES
K926028 · Theradapt Products, Inc. · Mar 1993
CHAIRS
K926025 · Theradapt Products, Inc. · Mar 1993
ELD-ARONDAK CHAIR
K926053 · Alert Care, Inc. · Mar 1993
K933000 · RECLINING GERI CHAIRS W/CASTERS & LAP TRAY
Download PDF Winco, Inc.