510(k) K772420

REAR FASTENING SAFETY STRAP by Fred Sammons, Inc. — Product Code IQB

K772420 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "REAR FASTENING SAFETY STRAP". The FDA issued a decision of Substantially Equivalent on January 5, 1978. The device falls under product code IQB (Belt, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1978
Date Received
December 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Belt, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type