Cleared Traditional

K982989 - QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR

K982989 is an FDA 510(k) clearance for QUICKIE SUSPENSION WHEELCHAIR SERIES MO..., manufactured by Sunrise Medical, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K982989 · Sunrise Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
40d
Days
Class 1
Risk

K982989 is an FDA 510(k) clearance for the QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Sunrise Medical, Inc. (Longmont, US). The FDA issued a Cleared decision on October 5, 1998 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 Sunrise Medical, Inc. devices

FDA 510(k) Submission Details - K982989

510(k) Number K982989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1998
Decision Date October 05, 1998
Days to Decision 40 days
Submission Type Traditional
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
76d faster than avg
Panel avg: 116d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
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 - IOR Wheelchair, Mechanical

All 355
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K982989.
ZIPPIE GS, MODEL # EIZGS
K983639 · Sunrise Medical, Inc. · Oct 1998
MOMENTUM NO. FS008 WHEELCHAIR
K982099 · Sriram Enterprises D.B.A. Momentum Group · Oct 1998
PANTHER WHEELCHAIR
K982849 · Snug Seat, Inc. · Oct 1998
MANUAL WHEELCHAIR
K982607 · G. Hirsch and Co., Inc. · Aug 1998
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
K982336 · Invacare Corp. · Aug 1998
MYCYCLE, HANDMASTER, VICTORY
K981557 · Richvale , Ltd. · Jul 1998