Rinovum Women'S Health, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Rinovum Women'S Health, Inc. makes
Rinovum Women’s Health, Inc. manufactures The Stork OTC, a Class II over-the-counter vaginal device designed for pelvic floor support and urinary incontinence management.
The company’s product portfolio is regulated under FDA 510(k) clearance as a Class II device and is listed in the FDA 510(k) registry. The manufacturer is based in the United States.
Catalogue
The Stork Otc Ref K140186
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Rinovum Women'S Health, Inc., initiated on 2019-05-02. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 2 May 2019 Z-1952-2019 Class II Terminated The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).
Frequently asked questions
How many devices does Rinovum Women'S Health, Inc. have in the registry?
The registry currently lists 1 device for Rinovum Women'S Health, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rinovum Women'S Health, Inc.'s devices?
Among its 1 most recently registered device, Rinovum Women'S Health, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Rinovum Women'S Health, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Rinovum Women'S Health, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rinovum Women'S Health, Inc.?
FDA recall records list 1 recall initiated by Rinovum Women'S Health, Inc., the most recent initiated on 2 May 2019. 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 Rinovum Women'S Health, Inc. in the registry?
The most recently registered devices listed for Rinovum Women'S Health, Inc. include THE STORK OTC.