510(k) K860837

HOYER ONE-TOUCH POWER LIFTER by Ted Hoyer & Co., Inc. — Product Code FSA

K860837 is an FDA 510(k) premarket notification submitted by Ted Hoyer & Co., Inc. for the device "HOYER ONE-TOUCH POWER LIFTER". The FDA issued a decision of Substantially Equivalent on March 27, 1986. The device falls under product code FSA (Lift, Patient, Non-Ac-Powered), a Class I device regulated under 21 CFR 880.5510. Ted Hoyer & Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1986
Date Received
March 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lift, Patient, Non-Ac-Powered
Device Class
Class I
Regulation Number
880.5510
Review Panel
HO
Submission Type