510(k) K033438

BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 by Bruno Independent Living Aids, Inc. — Product Code ILK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2003
Date Received
October 28, 2003
Clearance Type
Special
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.