Question 1

What types of medical devices does Addaday LLC manufacture?

Accepted Answer

Addaday LLC specializes in single-use transcutaneous electrical stimulation (TENS) electrodes. These electrodes are designed for temporary skin contact during therapeutic procedures, such as pain relief or muscle stimulation, and are intended to be used with external electrical stimulation devices.

Question 2

Where is Addaday LLC based?

Accepted Answer

Addaday LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution purposes, particularly when addressing FDA-related inquiries.

Question 3

Which regulatory registries or databases list Addaday LLC’s devices?

Accepted Answer

Addaday 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 U.S., ensuring traceability and compliance with regulatory requirements.

Question 4

How are Addaday LLC’s devices classified under FDA regulations?

Accepted Answer

Addaday LLC’s TENS electrodes fall under FDA Class II classification. This classification is assigned based on the device’s risk level and intended use, requiring special controls beyond general controls to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Addaday	EMS Type A	FDA UDI	Class II	Active
Addaday	EMS Type B	FDA UDI	Class II	Active
Addaday	EMS Type C	FDA UDI	Class II	Active
Addaday	EMS Type D	FDA UDI	Class II	Active

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