Little Rapids Corporation
United Statesfrom the FDA registration address FDA establishment FEI 1000049086
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 1
Catalogue
Procedure Mask Ref K220377
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000049086
- Address
- 2273 Larsen Rd, GREEN BAY, WI, 54303
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 27 Dec 2017 Z-0578-2018 Class II Terminated The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.
Frequently asked questions
How many devices does Little Rapids Corporation have in the registry?
The registry currently lists 1 device for Little Rapids Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Little Rapids Corporation's devices?
Among its 1 most recently registered device, Little Rapids Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Little Rapids Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Little Rapids Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Little Rapids Corporation?
FDA recall records list 1 recall initiated by Little Rapids Corporation, the most recent initiated on 27 Dec 2017. 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 Little Rapids Corporation in the registry?
The most recently registered devices listed for Little Rapids Corporation include Procedure Mask.