Cleared Traditional

DOLOMITE ROLLATOR (K921917) - FDA 510(k) Clearance

Class I Physical Medicine device.

K921917 · Seamark Technologies · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
33d
Days
Class 1
Risk

K921917 is an FDA 510(k) clearance for the DOLOMITE ROLLATOR. Classified as Chair, With Casters (product code INM), Class I - General Controls.

Submitted by Seamark Technologies (Boca Raton, US). The FDA issued a Cleared decision on May 26, 1992 after a review of 33 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 Seamark Technologies devices

Submission Details

510(k) Number K921917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1992
Decision Date May 26, 1992
Days to Decision 33 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.