Cleared Traditional

K133855 - BREEZY ELEGANCE

K133855 is an FDA 510(k) clearance for BREEZY ELEGANCE, manufactured by Sunrise Medical (Us), LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K133855 · Sunrise Medical (Us), LLC · Physical Medicine device
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Jan 2014
Decision
43d
Days
Class 1
Risk

K133855 is an FDA 510(k) clearance for the BREEZY ELEGANCE. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Sunrise Medical (Us), LLC (Fresno, US). The FDA issued a Cleared decision on January 31, 2014 after a review of 43 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 (Us), LLC devices

FDA 510(k) Submission Details - K133855

510(k) Number K133855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2013
Decision Date January 31, 2014
Days to Decision 43 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
73d faster than avg
Panel avg: 116d · This submission: 43d
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 324
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K133855.
VALENTINE STEEL WHEELCHAIR
K130017 · Valentine Intl. , Ltd. · May 2014
EZ TRANSPORT CHAIR
K130517 · Harris Medical, LLC · Feb 2014
MANUAL WHEELCHAIR
K132257 · Zhejiang Jiafeng Electrical & Mechanial Co., Ltd. · Feb 2014
CAPELLA
K130788 · Future Mobility Healthcare, Inc. · Dec 2013
SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
K130848 · Shanghai Phoenix Medical Equipment Co., Ltd. · Nov 2013
TX WHEELCHAIR CHASSIS
K131336 · Jcm Seating Solutions, Ltd. · Oct 2013