510(k) K940919

CHIEF SR by Redman, Inc. — Product Code IPL

K940919 is an FDA 510(k) premarket notification submitted by Redman, Inc. for the device "CHIEF SR". The FDA issued a decision of SN on Feb 3, 1995. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Redman, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
Feb 3, 1995
Date Received
Feb 24, 1994
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