Ralston Group
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Feminine Personal Trainer (FPT) Ref K171896
Regimes: 510(k) Registry: 510(k)
FDA recalls
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
- 12 Jul 2019 Z-2087-2019 Class II Terminated The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.
Full distribution text
- 12 Jul 2019 Z-2087-2019 Class II Terminated The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.
Frequently asked questions
How many devices does Ralston Group have in the registry?
The registry currently lists 1 device for Ralston Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ralston Group's devices?
Among its 1 most recently registered device, Ralston Group has devices listed in FDA 510(k) (1 device).
What risk classes do Ralston Group's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ralston Group's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ralston Group?
FDA recall records list 1 recall initiated by Ralston Group, the most recent initiated on 12 Jul 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 Ralston Group in the registry?
The most recently registered devices listed for Ralston Group include Feminine Personal Trainer (FPT).