Inovel, LLC
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Inovel, LLC makes
Inovel, LLC manufactures N95 particulate respirators and surgical masks, including models designed for medical and industrial use. These devices are engineered to filter airborne particles and protect against infectious aerosols, with variations for different fit and fluid resistance requirements.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. These devices are intended for use in healthcare settings and comply with U.S. standards for respiratory protection. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Inovel, LLC, the earliest on 2006-02-20 and the most recent on 2008-07-23. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 23 Jul 2008 Z-1576-2009 Unclassified (pre-2012) Terminated Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.
2006
- 20 Feb 2006 Z-0587-06 Unclassified (pre-2012) Terminated Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number
Frequently asked questions
How many devices does Inovel, LLC have in the registry?
The registry currently lists 5 devices for Inovel, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inovel, LLC's devices?
Among its 5 most recently registered devices, Inovel, LLC has devices listed in FDA 510(k) (5 devices).
What risk classes do Inovel, LLC's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Inovel, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Inovel, LLC?
FDA recall records list 2 recalls initiated by Inovel, LLC, the most recent initiated on 23 Jul 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Inovel, LLC in the registry?
The most recently registered devices listed for Inovel, LLC include INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP, INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS and INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS.