510(k) K103122

C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG by Aat Alber Antriebstechnik GmbH — Product Code ILK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2010
Date Received
October 21, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport, Patient, Powered
Device Class
Class II
Regulation Number
890.5150
Review Panel
PM
Submission Type

A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.