Cleared Traditional

K061010 - FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR

K061010 is an FDA 510(k) clearance for FUTURE MOBILITY HEALTHCARE INC. ORION I..., manufactured by Future Mobility Healthcare, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K061010 · Future Mobility Healthcare, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
41d
Days
Class 1
Risk

K061010 is an FDA 510(k) clearance for the FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL W.... Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Future Mobility Healthcare, Inc. (Mississauga, On, CA). The FDA issued a Cleared decision on May 23, 2006 after a review of 41 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 Future Mobility Healthcare, Inc. devices

FDA 510(k) Submission Details - K061010

510(k) Number K061010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2006
Decision Date May 23, 2006
Days to Decision 41 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
75d faster than avg
Panel avg: 116d · This submission: 41d
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 K061010.
COUGAR WHEELCHAIR
K061810 · R82 A/S · Aug 2006
MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S
K061694 · Medcare Manufacturing, Inc. · Jul 2006
ASTROTILT MANUAL WHEELCHAIR
K061475 · Pdg Product Design Group, Inc. · Jun 2006
7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L
K061273 · Nova Ortho-Med, Inc. · May 2006
TRIPOD
K060926 · Freedom Designs, Inc. · May 2006
FLIGHT
K061186 · Aero Innovative Research, Inc. · May 2006