510(k) K840796

TENDER LIFTING CARE by Lancer Assoc. — Product Code FRZ

K840796 is an FDA 510(k) premarket notification submitted by Lancer Assoc. for the device "TENDER LIFTING CARE". The FDA issued a decision of Substantially Equivalent on April 20, 1984. The device falls under product code FRZ (Device, Patient Transfer, Powered), a Class II device regulated under 21 CFR 880.6775. Lancer Assoc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1984
Date Received
February 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Patient Transfer, Powered
Device Class
Class II
Regulation Number
880.6775
Review Panel
HO
Submission Type