510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863511Substantially Equivalent

Immobilizing Vacuum Matress (Ivm)

Omnium Services Partners, Inc., Winter Park FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863511 is the FDA 510(k) clearance record for IMMOBILIZING VACUUM MATRESS (IVM), a class I device, cleared for Omnium Services Partners, Inc. on under FDA product code FPP (Stretcher, Hand-Carried). FDA records list one 510(k) clearance for Omnium Services Partners, Inc. As of , FDA records show no recalls naming K863511.

Clearance record

Decision date
Received
(16 days to decision)
Product code
FPP Stretcher, Hand-Carried
Regulation
21 CFR 880.6900
Device class
Class I
Review panel
General Hospital
Applicant
Omnium Services Partners, Inc. 1414 Gay Dr., Winter Park FL
Third party review
No

Clearances, product code FPP

Trailing 12 months

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

FDA records show no clearances under product code FPP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPP, 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