Cleared Special

K983677 - QUICKIE G SERIES, MODEL G-424

K983677 is an FDA 510(k) clearance for QUICKIE G SERIES, manufactured by Sunrise Medical, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 18-day FDA review.

K983677 · Sunrise Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
18d
Days
Class 2
Risk

K983677 is an FDA 510(k) clearance for the QUICKIE G SERIES, MODEL G-424. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Sunrise Medical, Inc. (Longmont, US). The FDA issued a Cleared decision on November 6, 1998 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sunrise Medical, Inc. devices

FDA 510(k) Submission Details - K983677

510(k) Number K983677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date November 06, 1998
Days to Decision 18 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 116d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 499
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K983677.
QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300
K981462 · Sunrise Medical, Inc. · Nov 1998
ALPHATRAC, MODEL A200
K982815 · Teftec Corp. · Nov 1998
BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD
K983520 · Sunrise Medical, Inc. · Nov 1998
ACTION STORM RANGER II, ACTION STORM POWER 9000
K982064 · Invacare Corp. · Oct 1998
MP-3 POWER BASE CHAIR
K982066 · Merits Health Products., Inc. · Aug 1998
SCOUT
K982158 · Burke, Inc. · Aug 1998