Helio A7 Manual Wheelchair, Move Manual Wheelchair

FDA 510(k) K143101 · Motion Composites

Substantially Equivalent

510(k) numberK143101

Submission

Device name
Helio A7 Manual Wheelchair, Move Manual Wheelchair
Applicant
Motion Composites
Saint-Roch-De-L' Achigan, CA
Received
October 29, 2014
Decision date
May 1, 2015
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 Helio A7 Manual Wheelchair, Move Manual Wheelchair cleared by the FDA?

Helio A7 Manual Wheelchair, Move Manual Wheelchair (K143101) received a 510(k) decision of Substantially Equivalent on May 1, 2015, 184 days after the submission was received.

What is the product code of K143101?

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