REGAL MOTOTRIZED 3 WHEELED VEHICLE


Device Classification Name

wheelchair, powered

510(k) Number K011227
Device Name REGAL MOTOTRIZED 3 WHEELED VEHICLE
Original Applicant
BRUNO INDEPENDENT LIVING AIDS, INC.
1780 executive dr.
p.o. box 84
oconomowoc, 
WI 
53066

Original Contact richard a keller
Regulation Number 890.3860
Classification Product Code
ITI  
Date Received 04/23/2001
Decision Date 05/11/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No