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INOVO, INC.

United States·US-MF-000023457

Last updated May 23, 2026

Information

Country: United States
Address: 401, Leonard Blvd. North, Lehigh Acres, United States
Website: www.drivemedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 516 760 7712
PRRC Contact: Cynthia Torres
EUDAMED SRN: US-MF-000023457
FDA FEI Number: —
DUNS Number: 015954530

Catalogue (46)

Device	Model / Reference	Registries	Class	Status
Drive	OM-812	FDA UDI	Class II	Active
Pure Concentrator	CH5000S	FDA UDI	Class II	Unknown
Evolution	OM-904J	FDA UDI	Class II	Unknown
Economizer Conserving Regulator	IN4606-L-BLUE-SALTER	FDA UDI	Class II	Unknown
Evolution	OM-900A	FDA UDI	Class II	Active
Bonsai	INT-812D	FDA UDI	Class II	Unknown
Cypress	OM-501A	FDA UDI	Class II	Unknown
Evolution	OM-950	FDA UDI	Class II	Active
Bonsai	OM-810	FDA UDI	Class II	Unknown
Economizer Conserving Regulator	IN4606-L-BLUE	FDA UDI	Class II	Unknown
Accupulse Single Lumen Conserving Regulator	IN6505-L-BLUE	FDA UDI	Class II	Unknown
Evolution	OM-900CE	FDA UDI	Class II	Active
SmartDose Evolution	OM-975	FDA UDI	Class II	Active
Evolution™	OM-924	FDA UDI	Class II	Active
Evolution	OM-903J	FDA UDI	Class II	Unknown
Bonsai	INT-812M6	FDA UDI	Class II	Active
Economizer Conserving Regulator	IN4606-L-GREEN-SALTER	FDA UDI	Class II	Unknown
Oxymizer	O-224	FDA UDI	Class II	Active
Evolution	OM-900CE	FDA UDI	Class II	Active
Evolution™	OM-900	FDA UDI	Class II	Active
Evolution™	OM-900M	FDA UDI	Class II	Active
Purefill	PF1100	FDA UDI	Class II	Unknown
Smartdose	CTOX-MN02	FDA UDI	Class II	Active
Bonsai	INT-812M9	FDA UDI	Class II	Active
Cga-870 With Oxygen Cylinder	CYLM6TFV	FDA UDI	Class I	Unknown
Economizer Conserving Regulator	IN4606-L-GREEN	FDA UDI	Class II	Unknown
Evolution	OM-900B	FDA UDI	Class II	Unknown
Pure Concentrator	CH5000	FDA UDI	Class II	Unknown
Evolution	OM-950	FDA UDI	Class II	Active
Bonsai	OM-810CE	FDA UDI	Class II	Unknown
Drive	OM-900A	FDA UDI	Class II	Active
Bonsai	INT-812ML6	FDA UDI	Class II	Active
Cga-870 With Oxygen Cylinder	CYLM9TFV	FDA UDI	Class I	Unknown
Oxymizer	F-224	FDA UDI	Class II	Unknown
Bonsai	OM-812	FDA UDI	Class II	Active
Cga-870 With Oxygen Cylinder	CYLDTFV	FDA UDI	Class I	Unknown
Cga-870 With Oxygen Cylinder	CYLML6TFV	FDA UDI	Class I	Unknown
Bonsai Oxygen Conserving Device	OM-824	EUDAMEDFDA UDI	Class IIb	Active
Inovo, Inc. Accupulse Single Lumen Conserving Regulator	K060751	FDA 510(k)	Class II	Active
Chad Therapeutic Evolution Electronic Oxygen Conserver With Motion	K113111	FDA 510(k)	Class II	Active
Purefill Oxygen Compressor	K141967	FDA 510(k)	Class II	Active
Chad Therapeutic Evolution Electronic Oxygen Conserver	K103392	FDA 510(k)	Class II	Active
Inovo, Inc, Economizer Conserving Regulator	K031983	FDA 510(k)	Class II	Active
Inovo, Inc. Independence Oxygen Conserving Regulator	K051540	FDA 510(k)	Class II	Active
Oxymizer Pendant Conserving Device	P-224	EUDAMEDFDA UDI	Class IIa	Active
Bonsai Oxygen Conserving Device	OM-812CE	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Drive Medical GmbH & Co. KG DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 26, 2019	Z-2099-2019	—	terminated	The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Oct 9, 2017	Z-0407-2018	—	terminated	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).
Jul 21, 2016	Z-0760-2017	—	terminated	Device can fail during operation.