Cleared Special

K042612 - JAZZY 600

K042612 is an FDA 510(k) clearance for JAZZY 600, manufactured by Pride Mobility Products Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 12-day FDA review.

K042612 · Pride Mobility Products Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
12d
Days
Class 2
Risk

K042612 is an FDA 510(k) clearance for the JAZZY 600. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on October 6, 2004 after a review of 12 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 Pride Mobility Products Corp. devices

FDA 510(k) Submission Details - K042612

510(k) Number K042612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2004
Decision Date October 06, 2004
Days to Decision 12 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
104d faster than avg
Panel avg: 116d · This submission: 12d
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 K042612.
GENEMAX POWER WHEELCHAIR, PW3
K042748 · Genemax Medical Products Industry Corp. · Nov 2004
GENEMAX POWER WHEELCHAIR, PW4
K042749 · Genemax Medical Products Industry Corp. · Nov 2004
HOVEROUND MPV-5 POWERCHAIR
K042545 · Hoveround Corp. · Oct 2004
ADVENTURE A10
K042535 · Ulrich Alber GmbH · Oct 2004
POWERED WHEELCHAIR, MODEL B-500
K041208 · Otto Bock Healthcare LP · Oct 2004
POWERED WHEELCHAIR, MODEL B-600
K041210 · Otto Bock Healthcare LP · Oct 2004