Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair

FDA 510(k) K061010 · Future Mobility Healthcare, Inc.

Substantially Equivalent

510(k) numberK061010

Submission

Device name
Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair
Applicant
Future Mobility Healthcare, Inc.
Mississauga, On, CA
Received
April 12, 2006
Decision date
May 23, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IOR – Wheelchair, Mechanical
Device class
Class I (low risk)
Regulation
21 CFR 890.3850
Specialty
Physical Medicine

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.

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Questions and answers

When was Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair cleared by the FDA?

Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair (K061010) received a 510(k) decision of Substantially Equivalent on May 23, 2006, 41 days after the submission was received.

What is the product code of K061010?

The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.