Question 1

What types of medical devices does Oak Tech LLC manufacture?

Accepted Answer

Oak Tech LLC specializes in electric nasal aspirators. These devices are battery-powered and intended to help clear mucus from the noses of infants and young children. The design includes disposable or reusable suction tips to ensure safe and effective use.

Question 2

Where is Oak Tech LLC based?

Accepted Answer

Oak Tech LLC is based in the United States. The company’s headquarters and operations are located within the country.

Question 3

Which regulatory registries list Oak Tech LLC’s devices?

Accepted Answer

Oak Tech LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US.

Question 4

How are Oak Tech LLC’s devices classified under US regulations?

Accepted Answer

Oak Tech LLC’s electric nasal aspirators are classified as Class II medical devices under US regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Grownsy	NASA006	FDA UDI	Class II	Active
Grownsy	BC023	FDA UDI	Class II	Active
Grownsy	BC024	FDA UDI	Class II	Active
Grownsy	NASA006	FDA UDI	Class II	Active
Grownsy	BC023	FDA UDI	Class II	Active
Grownsy	NASA006	FDA UDI	Class II	Active
Grownsy	BC024	FDA UDI	Class II	Active
Grownsy	BC024	FDA UDI	Class II	Active
Grownsy	BC023	FDA UDI	Class II	Active
Grownsy	NASA006	FDA UDI	Class II	Active
Grownsy	BC023	FDA UDI	Class II	Active
Grownsy	BC024	FDA UDI	Class II	Active
Grownsy	BC023	FDA UDI	Class II	Active

Oak Tech LLC

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