510(k) K031621

HERO 1, MODEL LY-ESB220 by Comfort Orthopedic Co., Ltd. — Product Code IPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2004
Date Received
May 23, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type