510(k) K946169

ACTIC 2002 by North Atlantic Rehabilitation, Inc. — Product Code BXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1995
Date Received
December 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type