Question 1

What types of medical devices does IGEA SPA manufacture?

Accepted Answer

IGEA SPA specializes in bone growth ultrasonic stimulators, such as devices branded as Accelstim and AccelStim. These devices are engineered to aid bone healing and regeneration by applying controlled ultrasonic stimulation, primarily serving orthopedic and trauma care applications.

Question 2

Where is IGEA SPA based?

Accepted Answer

IGEA SPA is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance, particularly in the context of US-based medical device authorizations.

Question 3

Which regulatory registries list IGEA SPA’s devices?

Accepted Answer

IGEA SPA’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class III devices, which require strict premarket approval or de novo clearance in the US.

Question 4

How are IGEA SPA’s devices classified in the US?

Accepted Answer

IGEA SPA’s bone growth ultrasonic stimulators fall under Class III classification in the US. This classification is the highest risk tier, necessitating rigorous premarket approval (PMA) or de novo clearance before commercialization, due to their direct impact on patient safety and efficacy.

Device	Model / Reference	Registries	Class	Status
Accelstim	UBHS-02	FDA UDI	Class III	Active
Accelstim	UBHS-02	FDA UDI	Class III	Active
Accelstim	UBHS-02	FDA UDI	Class III	Active
Accelstim	UBHS-02	FDA UDI	Class III	Active
Accelstim	UBHS-02	FDA UDI	Class III	Active
AccelStim	UBHS-02	FDA UDI	Class III	Active

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