510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854058Substantially Equivalent

Pk-Ac Powered Patient Manupulating Device

Mannesmann Demag Corp., Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854058 is the FDA 510(k) clearance record for PK-AC POWERED PATIENT MANUPULATING DEVICE, a class II device, cleared for Mannesmann Demag Corp. on under FDA product code FNG (Lift, Patient, Ac-Powered). FDA records list one 510(k) clearance for Mannesmann Demag Corp. As of , FDA records show no recalls naming K854058.

Clearance record

Decision date
Received
(145 days to decision)
Product code
FNG Lift, Patient, Ac-Powered
Regulation
21 CFR 880.5500
Device class
Class II
Review panel
General Hospital
Applicant
Mannesmann Demag Corp. 29201 Aurora Rd., Solon OH
Third party review
No

Clearances, product code FNG

Trailing 12 months

FDA records hold no clearances under product code FNG in the trailing twelve months.

FDA records show no clearances under product code FNG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260