Sequal Technologies Co., Ltd.
Country not established
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sequal Technologies Co., Ltd. makes
Sequal Technologies Co., Ltd. manufactures portable and stationary oxygen concentrators, including models like the INTEGRA 6400-OM, OMNI 2 System, and MESA II T2000 Series. These devices extract oxygen from ambient air for medical use, catering to both home and clinical settings. The portfolio includes variable-flow concentrators and fixed-output systems designed for continuous oxygen therapy.
The company’s oxygen concentrators are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. Products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Integra Oxygen Concentrators Model 6400-Om Ref K003472
Regimes: 510(k) Registry: 510(k)Integra Oxygen Concentrator, Model 6323A-Om-10 Ref K042262
Regimes: 510(k) Registry: 510(k)Omni 2 Oxygen System Ref K083163
Regimes: 510(k) Registry: 510(k)Mesa Ii Oxygen Concentrator Model: T2000 Series Ref K100920
Regimes: 510(k) Registry: 510(k)Omni Oxygen System, Model 1000 Ref K013931
Regimes: 510(k) Registry: 510(k)Mesa Oxygen Concentrator, Model 2-6000 Series Ref K091541
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Sequal Technologies Co., Ltd., initiated on 2009-10-01. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 1 Oct 2009 Z-0567-2010 Unclassified (pre-2012) Terminated Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.
Full distribution text
- 1 Oct 2009 Z-0567-2010 Unclassified (pre-2012) Terminated Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.
Frequently asked questions
How many devices does Sequal Technologies Co., Ltd. have in the registry?
The registry currently lists 6 devices for Sequal Technologies Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sequal Technologies Co., Ltd.'s devices?
Among its 6 most recently registered devices, Sequal Technologies Co., Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Sequal Technologies Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sequal Technologies Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sequal Technologies Co., Ltd.?
FDA recall records list 1 recall initiated by Sequal Technologies Co., Ltd., the most recent initiated on 2009-10-01. 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 Sequal Technologies Co., Ltd. in the registry?
The most recently registered devices listed for Sequal Technologies Co., Ltd. include INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM, INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10, OMNI 2 OXYGEN SYSTEM and MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES.