Inovo, Inc.
Medical device manufacturer in Lehigh Acres, FL.
6510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K141967 | Purefill Oxygen CompressorCAW · Traditional | 11/07/2014SE |
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | 12/08/2011SE |
| K103392 | Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special | 12/17/2010SE |
| K060751 | Inovo, Inc. Accupulse Single Lumen Conserving RegulatorNFB · Traditional | 07/18/2006SE |
| K051540 | Inovo, Inc. Independence Oxygen Conserving RegulatorNFB · Traditional | 09/21/2005SE |
| K031983 | Inovo, Inc, Economizer Conserving RegulatorNFB · Traditional | 09/15/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2099-2019 Class II | Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow…The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. | 04/26/2019Terminated |
| Z-0407-2018 Class II | PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000SPost-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an… | 10/09/2017Terminated |
| Z-0760-2017 Class II | INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can…Device can fail during operation. | 07/21/2016Terminated |