Cleared Traditional

K921917 - DOLOMITE ROLLATOR

K921917 is an FDA 510(k) clearance for DOLOMITE ROLLATOR, manufactured by Seamark Technologies. The device is a Class 1 Physical Medicine device with product code INM cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K921917 · Seamark Technologies · Physical Medicine device
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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

FDA 510(k) Submission Details - K921917

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.

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 7
Devices cleared under the same product code (INM) and FDA review panel - the closest regulatory comparables to K921917.
NISSIN PEDIATRIC SERIES WHEELCHAIR
K063521 · Nissin Medical, Inc. · Feb 2007
SHOWER CHAIRS
K922045 · Medical Device Inspection Co., Inc. · May 1992
WALK & ROLL
K841700 · Maddak, Inc. · May 1984
PORTABLE TRANSIT CHAIR
K840638 · Poirier S.A. · Mar 1984
OB TRIPP TRANSPORT CHAIR
K830850 · Lic-Orthion · Apr 1983
ROLLCHAIR, ORTHO BUCKET SEAT
K790560 · Maddak, Inc. · Apr 1979