Data / Medical devices / United States / Inovo Inc.
Inovo Inc.: FDA-registered device maker in Lehigh Acres, FL, United States, 7 510(k) clearances
Inovo Inc. is registered with the FDA (registration 1062191) in Lehigh Acres, FL, United States. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 5, 2013. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1062191
- FEI number
- 3000719543
- Address
- 401 Leonard Blvd N, Lehigh Acres, FL, United States, 33971
- Owner or operator
- Medical Depot Inc dba Drive DeVilbiss Healthcare (9028104)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 13, 1997
- Registered through
- 2026
- Brand names listed
- 35BWBE-A-SC04, 35BWBE-A-SC05, 35BWBE-B-SC04, 35BWBE-B-SC05, 35BWBE-CUSTOM-SC05, 35BWBE-FM-SC04, 35BWBE-FM-SC05, 35MCBE-A-SC04 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Manufacturer | accessdata.fda.gov |
| Adaptor, Recreational | ILT | 1 | Manufacturer | accessdata.fda.gov |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Manufacturer | accessdata.fda.gov |
| Conserver, Oxygen | NFB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lift, Patient, Ac-Powered | FNG | 2 | Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2013 | K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Inspirx, Inc. | accessdata.fda.gov |
| December 8, 2011 | K113111 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION | NFB | Substantially Equivalent | Inovo, Inc. | accessdata.fda.gov |
| December 17, 2010 | K103392 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER | NFB | Substantially Equivalent | Inovo, Inc. | accessdata.fda.gov |
| May 29, 2009 | K090421 | MODEL 350G GAS CONSERVER | NFB | Substantially Equivalent | Inspired Technologies, Inc. | accessdata.fda.gov |
| May 7, 2007 | K070740 | CHAD THERAPEUTICS BONSAI MODEL 800 | NFB | Substantially Equivalent | Chad Therapeutics, Inc. | accessdata.fda.gov |
| March 19, 1984 | K834588 | OXYMIZER-PENDANT | NFB | Substantially Equivalent | Chad Therapeutics, Inc. | accessdata.fda.gov |
| April 2, 1983 | K830009 | OXYMIZER | NFB | Substantially Equivalent | Chad Therapeutics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 26, 2019 | 82793 | Class II | Terminated | Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratio | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. | accessdata.fda.gov |
| October 9, 2017 | 78883 | Class II | Terminated | PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S | 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). | accessdata.fda.gov |
| July 21, 2016 | 75312 | Class II | Terminated | INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders. | Device can fail during operation. | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Recreational
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Chair, With Casters
- All makers of Conserver, Oxygen
- All makers of Bottle, Collection, Vacuum
- All makers of Bed, Ac-Powered Adjustable Hospital
Updated June 5, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.