Question 1

What types of medical devices does Thorasys Thoracic Medical Systems Inc manufacture?

Accepted Answer

Thorasys Thoracic Medical Systems Inc specializes in pulmonary function analysis systems for adults. Their portfolio includes software solutions like the tremoFlo US, hardware systems such as the tremoflo C-100 Airwave Oscillometry, and accessories like disposable mouthpiece filters (e.g., Clearflo PFT Filter) and reusable sensor modules (e.g., tf C2 Sensor Module). These devices are designed to measure lung function and airflow resistance, helping clinicians assess respiratory health.

Question 2

Where is Thorasys Thoracic Medical Systems Inc based?

Accepted Answer

Thorasys Thoracic Medical Systems Inc is based in the United States. The company’s headquarters and operations are located within the country, where it develops, manufactures, and distributes its pulmonary function testing devices.

Question 3

Which regulatory registries or databases list Thorasys Thoracic Medical Systems Inc’s devices?

Accepted Answer

Thorasys Thoracic Medical Systems Inc’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the FDA’s Unique Device Identifier (UDI) system. These registries ensure compliance and traceability for Class II devices, which include their pulmonary function analysis systems and accessories.

Question 4

How are Thorasys Thoracic Medical Systems Inc’s devices classified under FDA regulations?

Accepted Answer

Thorasys Thoracic Medical Systems Inc’s devices fall under Class II classification by the FDA. This classification applies to moderate-risk medical devices that require special controls to ensure safety and effectiveness, such as pulmonary function testing systems and their associated accessories. Class II devices are authorised through processes like the 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device.

Device	Model / Reference	Registries	Class	Status
tremoFlo US Software	101345	FDA UDI	Class II	Active
Clearflo PFT Filter in bag	101421	EUDAMEDFDA UDI	Class II	Active
tremoflo C2 Device - Yellow - VTG 28554	102237	FDA UDI	Class II	Active
tremoflo C-100 Airwave Oscillometry - Support Arm	101923	EUDAMEDFDA UDI	Class II	Active
tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EU	102110	EUDAMEDFDA UDI	Class II	Active
tf C-100 Kit Vitalograph - Healthcare Edition (28500)	102181	FDA UDI	N/A	Active
tf C2 Sensor Module - clearflo	101664	EUDAMEDFDA UDI	Class II	Active
tremoflo C2 Device - clearflo	101711	FDA UDI	Class II	Active
TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L	101059	EUDAMEDFDA UDI	Class II	Active
tremoflo C2 Reference Test Load	101947	EUDAMEDFDA UDI	Class II	Active
tF C2 Sensor Module Labelled - Eco BVF	102233	EUDAMEDFDA UDI	Class II	Active
TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L	100986	EUDAMEDFDA UDI	Class II	Active
tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant Edition	102079	FDA UDI	Class II	Active
tF C-100 Unit-ClearFlo PFT filter compatible	101336	EUDAMEDFDA UDI	Class II	Active
tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition	101524	FDA UDI	Class II	Active
tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition	102585	EUDAMEDFDA UDI	Class II	Active
tremoflo C2 Airwave Oscillometry System and Accessories	102036	FDA UDI	Class II	Active
tf C-100 Kit Vitalograph - Clinical Trial Edition (28300)	101761	EUDAMEDFDA UDI	Class II	Active
tF Calibrated Reference Load 15cmH2O (2 Years Edition)	102069	FDA UDI	Class II	Active
Assembly of tremoflo US software and digital user manual CD	101640	FDA UDI	Class II	Active
tremoFlo C-100 Airwave Oscillometry System	K170185	FDA 510(k)	Class II	Active
tremoflo C2 Airwave Oscillometry System	K221024	FDA 510(k)	Class II	Active

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