Question 1

What types of medical devices does Innovo Medical manufacture?

Accepted Answer

Innovo Medical specializes in devices for direct patient care, including single-use transcutaneous electrical stimulation electrodes, manual nasal aspirators for infants, infrared skin thermometers for non-invasive temperature monitoring, pulse oximeters to measure blood oxygen levels, and transcutaneous electrical nerve stimulation (TENS) systems for pain relief. These products are designed for both clinical and home-use settings, emphasizing simplicity and ease of use.

Question 2

Where is Innovo Medical based, and where are its devices primarily regulated?

Accepted Answer

Innovo Medical is based in the United States. Its devices are regulated under FDA guidelines, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The regulatory classification—either Class I or Class II—determines the level of oversight, depending on the device’s risk profile and intended use within the U.S. market.

Question 3

Which regulatory registries or databases list Innovo Medical’s devices?

Accepted Answer

Innovo Medical’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, manufacturers, and regulators, allowing users to verify device details such as model numbers, specifications, and regulatory classifications. No other international regulatory listings are specified.

Question 4

How are Innovo Medical’s devices classified under FDA regulations?

Accepted Answer

Innovo Medical’s devices fall under two FDA classification tiers: Class I or Class II. Class I devices generally pose minimal risk and require less regulatory scrutiny, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification is based on factors like the device’s purpose, potential risks, and intended use environment, ensuring appropriate oversight aligned with their risk profiles.

Question 5

Are Innovo Medical’s devices intended for use outside the United States?

Accepted Answer

The provided information does not specify whether Innovo Medical’s devices are authorized for use outside the U.S. or listed in international regulatory databases. All references indicate compliance with FDA requirements, including UDI registration, which is specific to the U.S. market. For global use, additional regulatory pathways (e.g., CE marking for Europe or other regional standards) would typically be required.

Device	Model / Reference	Registries	Class	Status
Innovo	INV-FR201	FDA UDI	Class II	Active
Innovo	Japanese Gel - 4 pieces	FDA UDI	Class II	Active
Innovo	iP900AP	FDA UDI	Class II	Active
Innovo	iT300AG-L	FDA UDI	Class II	Active
Innovo	430J/PE	FDA UDI	Class II	Active
Innovo	m900BP	FDA UDI	Class II	Active
Innovo	INV-EF100	FDA UDI	Class II	Active
Innovo	iT300AB	FDA UDI	Class II	Active
Innovo	iSoothe INV-942R	FDA UDI	Class II	Active
Innovo	ZBH-BULB	FDA UDI	Class I	Active
Innovo	430C/DL-PE	FDA UDI	Class II	Active
Innovo	iT300AG-S	FDA UDI	Class II	Active
Innovo	INV-EF100	FDA UDI	Class II	Active
Innovo	CMS 50F Plus	FDA UDI	Class II	Active
Innovo	iSoothe E-946R-5	FDA UDI	Class II	Active
Innovo	INV-EF100	FDA UDI	Class II	Active
Innovo	Japanese Gel - 44 pieces	FDA UDI	Class II	Active

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