Manufacturer registered with FDA
Innovative Health Technologies (NZ) Limited
Dunedin, New Zealand. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12023–2023
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1New Zealand
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Innovative Health Technologies (NZ) Limited as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Innovative Health Technologies (NZ) Limited | 1 clearances | 2023–2023 | Below |
| Israel | AMAR | Manufacturer | Innovative Health Technologies (NZ) Limited | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Innovative Health Technologies (NZ) Ltd | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Innovative Health Technologies (NZ) Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | AVEOtsd | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Innovative Health Technologies (NZ) Limited as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Sep 2023 | K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: Shenzhen Kesite Digital Technology Co., Ltd. (1).
Also lists devices cleared under other names
Innovative Health Technologies (NZ) Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: University of Otago (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Dec 1999 | K993381 | TONGUE STABILIZER DEVICE | University of Otago | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Innovative Health Technologies (NZ) LimitedFDA reg. 3006786034 | Dunedin Otago, New Zealand | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023497). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.