Cleared Special

K083249 - QUICKIE RHYTHM

K083249 is an FDA 510(k) clearance for QUICKIE RHYTHM, manufactured by Sunrise Medical Hhg, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 49-day FDA review.

K083249 · Sunrise Medical Hhg, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
49d
Days
Class 2
Risk

K083249 is an FDA 510(k) clearance for the QUICKIE RHYTHM. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Sunrise Medical Hhg, Inc. (Longmont, US). The FDA issued a Cleared decision on December 23, 2008 after a review of 49 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 Hhg, Inc. devices

FDA 510(k) Submission Details - K083249

510(k) Number K083249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2008
Decision Date December 23, 2008
Days to Decision 49 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
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 298
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K083249.
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
K100350 · Hoveround Corp. · Mar 2010
JAZZY FRONTIE
K092961 · Pride Mobility Products Corp. · Oct 2009
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
K090108 · Hoveround Corp. · Mar 2009
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
K073134 · Invacare Corporation · Nov 2007
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
K071005 · Heartway Medical Products Co., Ltd. · May 2007
HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
K071006 · Heartway Medical Products Co., Ltd. · May 2007