Cleared Traditional

K904069 - BRODA NURSING CARE CHAIR

K904069 is an FDA 510(k) clearance for BRODA NURSING CARE CHAIR, manufactured by Broda Ent., Inc.. The device is a Class 1 Physical Medicine device with product code INN cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K904069 · Broda Ent., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
13d
Days
Class 1
Risk

K904069 is an FDA 510(k) clearance for the BRODA NURSING CARE CHAIR. Classified as Chair, Adjustable, Mechanical (product code INN), Class I - General Controls.

Submitted by Broda Ent., Inc. (Ontario, Canada, CA). The FDA issued a Cleared decision on September 17, 1990 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K904069

510(k) Number K904069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1990
Decision Date September 17, 1990
Days to Decision 13 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
103d faster than avg
Panel avg: 116d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

INN Device Classification - Class 1, General Controls

Product Code INN Chair, Adjustable, Mechanical
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 - INN Chair, Adjustable, Mechanical

All 25
Devices cleared under the same product code (INN) and FDA review panel - the closest regulatory comparables to K904069.
KAYE MODEL KIAO PELVIC/THIGH STABILIZER
K923095 · Kaye Products, Inc. · Jul 1992
CHAIR, ADJUSTABLE, MECHANICAL
K922061 · Kaye Products, Inc. · May 1992
ACTIVITY CHAIR
K921272 · Rifton Equipment For the Handicapped · Apr 1992
SHOWER-A-WAY
K902951 · Tri-S-Sales and Mfg. · Jul 1990
THE COMPANION NON-ELECTRIC LIFT CHAIR
K902600 · Innovative Medical Engineering, Inc. · Jun 1990
TOI-LIFT
K896814 · Mill-Tech Ent., Inc. · Feb 1990
K904069 · BRODA NURSING CARE CHAIR
Download PDF Broda Ent., Inc.