510(k) K780684

PATIENT LIFT by Orthopedic Equipment Co., Inc. — Product Code FSA

K780684 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "PATIENT LIFT". The FDA issued a decision of Substantially Equivalent on June 6, 1978. The device falls under product code FSA (Lift, Patient, Non-Ac-Powered), a Class I device regulated under 21 CFR 880.5510. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1978
Date Received
April 24, 1978
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