Cleared Traditional

K981462 - QUICKIE P100 SERIES

K981462 is an FDA 510(k) clearance for QUICKIE P100 SERIES, manufactured by Sunrise Medical, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K981462 · Sunrise Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
197d
Days
Class 2
Risk

K981462 is an FDA 510(k) clearance for the QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P1.... 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 197 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunrise Medical, Inc. devices

FDA 510(k) Submission Details - K981462

510(k) Number K981462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1998
Decision Date November 06, 1998
Days to Decision 197 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 232
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K981462.
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K993413 · Invacare Corp. · Dec 1999
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
K991119 · Invacare Corp. · Aug 1999
ARROW FWD POWER WHEELCHAIR
K991168 · Invacare Corp. · Jun 1999
ACTION STORM RANGER II, ACTION STORM POWER 9000
K982064 · Invacare Corp. · Oct 1998
MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
K950724 · Invacare Corp. · Aug 1995
MODEL MCC - MKIV MICRO COMPUTER CONTROLS
K940972 · Invacare Corp. · Jun 1994