510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Inovo Inc.

Lehigh Acres, FL, US

Inovo Inc. appears in FDA device records in Lehigh Acres, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Inovo Inc. in 2014.

Clearances by year, as a table
510(k) clearance decisions for Inovo Inc., by decision year
YearClearances
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K141967PUREFILL OXYGEN COMPRESSORCAWSubstantially Equivalent

Registered establishments

FDA registered establishments for Inovo Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10621913000719543Inovo Inc.401 Leonard Blvd N, Lehigh Acres, FL 33971 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2099-2019Inovo 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 ratios.The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.Class IITerminated
Z-0407-2018PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000SPost-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).Class IITerminated
Z-0760-2017INOVO 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain