FEI 3000719543
Inovo Inc.
401 Leonard Blvd N, Lehigh Acres, FL, US
MDR events30All time
Recalls3All time
Registered products9
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
9 product codes
Recent MDR events
30 on file
- DRIVE BEDJul 14, 2026MalfunctionMW5190724
- HOSPITAL BEDJun 22, 2026MalfunctionMW5189683
- DRIVE MEDICAL 3 POSITION GERI CHAIR RECLINERApr 15, 2026InjuryMW5186863
- DRIVE ADJUSTABLE HOSPITAL BEDFeb 2, 2026MalfunctionMW5183119
- DRIVE MEDICAL RTL12087 BATHROOM GRAB BAR FOR TOILETSAug 19, 2024InjuryMW5158617
- DRIVEMay 16, 2024MalfunctionMW5155062
- INOVO INC.Feb 21, 2024Malfunction1062191-2024-00001
- INOVO INC.Feb 21, 2024Malfunction1062191-2024-00002
- INOVOAug 24, 2023Malfunction3005328749-2023-00002
- INSPIRED BY DRIVEMay 1, 2023Injury3005328749-2023-00001
Recalls
3 on file
- TerminatedUnknown
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
View FDA record ↗ - TerminatedUnknown
Device can fail during operation.
View FDA record ↗ - TerminatedUnknown
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
View FDA record ↗
Compliance history
Matched by FEI 3000719543.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.