RegWardenFDA facility compliance records
Facility

Intensa, Inc.

3 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2016: 1 recalls; 2021: 1 recalls1’14’151’16’17’18’19’201’21’22’23’24’25’26
  • Recalls (3)

Devices registered here (1)

  • Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
    Product code LLI (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5100

Recalls & enforcement

  • Class IITerminated2021-03-24
    The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
  • Class IITerminated2016-09-30
    GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model U…
  • Class IITerminated2014-07-21
    The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Intensa, Inc. (FEI 3008533516) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008533516-intensa-inc/

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