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510(k) K854058

PK-AC POWERED PATIENT MANUPULATING DEVICE by Mannesmann Demag Corp. — Product Code FNG

K854058 is an FDA 510(k) premarket notification submitted by Mannesmann Demag Corp. for the device "PK-AC POWERED PATIENT MANUPULATING DEVICE". The FDA issued a decision of Substantially Equivalent on February 25, 1986. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1986
Date Received
October 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lift, Patient, Ac-Powered
Device Class
Class II
Regulation Number
880.5500
Review Panel
HO
Submission Type

Other clearances for product code FNG

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  • K041503 — HOVERJACK AIR PATIENT LIFT DEVICE (August 12, 2004)
  • K940872 — PATIENT SUPPORT SYSTEM (October 13, 1994)
  • K935351 — A.C. POWER PATIENT LIFT (February 28, 1994)
  • K926411 — SAF-LIFT/SAF-KARY (March 31, 1993)
  • K912769 — PATIENT LIFT AND TRANSPORT (October 2, 1991)
  • K905414 — MANGAR BOOSTER (March 5, 1991)
  • K895677 — THE MURRAY MOBILIFT(TM) (October 26, 1990)
  • K903723 — BARRIER FREE CEILING LIFT, MDLS HRS-1/2F,1/4F,1/6F (September 24, 1990)
  • K896848 — LIFT MASTER PATIENT LIFT (May 29, 1990)

FDA data resources