Getinge (Suzhou) Co., Ltd.
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Getinge (Suzhou) Co., Ltd. makes
Getinge (Suzhou) Co., Ltd. manufactures pneumatic compression devices, including the Flowtron DVT5 Small Calf Garment for preventing deep vein thrombosis (DVT) in the lower leg, and the Flowtron ACS900, a sequential compression system designed for active circulation support.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance in the United States. The company operates as a subsidiary based in the US.
Catalogue
Flowtron DVT5 Small Calf Garment Ref K172103
Regimes: 510(k) Registry: 510(k)Flowtron ACS900 Ref K143438
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Getinge (Suzhou) Co., Ltd., initiated on 2021-04-15. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. 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 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 15 Apr 2021 Z-1788-2021 Class II Terminated There is a potential for abnormal inflation of the mattress.
Frequently asked questions
How many devices does Getinge (Suzhou) Co., Ltd. have in the registry?
The registry currently lists 2 devices for Getinge (Suzhou) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Getinge (Suzhou) Co., Ltd.'s devices?
Among its 2 most recently registered devices, Getinge (Suzhou) Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Getinge (Suzhou) Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Getinge (Suzhou) Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Getinge (Suzhou) Co., Ltd.?
FDA recall records list 1 recall initiated by Getinge (Suzhou) Co., Ltd., the most recent initiated on 15 Apr 2021. 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 Getinge (Suzhou) Co., Ltd. in the registry?
The most recently registered devices listed for Getinge (Suzhou) Co., Ltd. include Flowtron DVT5 Small Calf Garment and Flowtron ACS900.