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
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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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 116d · 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 549
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K083249 · QUICKIE RHYTHM
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