510(k) K921894

RIFTON MOBILE PRONE STANDERS by Rifton Equipment For the Handicapped — Product Code IPL

K921894 is an FDA 510(k) premarket notification submitted by Rifton Equipment For the Handicapped for the device "RIFTON MOBILE PRONE STANDERS". The FDA issued a decision of Substantially Equivalent on May 26, 1992. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Rifton Equipment For the Handicapped has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1992
Date Received
April 22, 1992
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