Cleared Traditional

BRODA NURSING CARE CHAIR (K904069) - FDA 510(k) Clearance

Class I Physical Medicine device.

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.

View all Broda Ent., Inc. devices

Submission Details

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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.