Innovative Health Technologies (Nz), Ltd.
NZ Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
FDA establishments
- Innovative Health Technologies (NZ) Limited Dunedin Otago · NZ FEI 3006786034
What Innovative Health Technologies (Nz), Ltd. makes
Innovative Health Technologies (NZ), Ltd. manufactures the AVEOtsd, a tongue-stabilizing mouthpiece designed to support oral motor function and speech clarity.
The AVEOtsd is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Innovative Health Technologies (NZ), Ltd. manufacture?
Innovative Health Technologies (NZ), Ltd. specializes in the AVEOtsd, a tongue-stabilizing mouthpiece. This device is designed to assist with oral motor function and improve speech clarity for users.
Where is Innovative Health Technologies (NZ), Ltd. based?
The company is headquartered in the United States. While the name includes '(NZ)', this appears to be part of its branding or legal structure rather than indicating a New Zealand location.
How are the devices manufactured by Innovative Health Technologies (NZ), Ltd. classified under regulatory standards?
The AVEOtsd is classified as a Class II medical device. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries or pathways list the devices made by Innovative Health Technologies (NZ), Ltd.?
The AVEOtsd is listed under the FDA’s 510(k) pathway, meaning it has been submitted for premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. This pathway is used for Class II devices to demonstrate compliance with regulatory requirements.
Information
- Country
- NZ