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Sign in to claim this brandAmplivox, Ltd.
US
Last updated May 23, 2026
What Amplivox, Ltd. makes
Amplivox, Ltd. manufactures diagnostic equipment for hearing and balance assessment, including vestibulo-auditory analysis systems, tone audiometers, and impedance audiometers. These devices are designed to measure auditory function, middle-ear impedance, and vestibular responses in clinical settings. The portfolio includes standalone and integrated systems for audiological testing and evaluation.
The company’s products fall under FDA Class II devices and are authorised through the 510(k) premarket notification process and the FDA’s Unique Device Identifier (UDI) system. These devices are listed in the FDA’s regulatory databases, ensuring compliance with US medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Amplivox, Ltd. manufacture?
Amplivox, Ltd. specializes in diagnostic equipment for hearing and balance assessment. Their portfolio includes vestibulo-auditory analysis systems, which evaluate vestibular function, as well as tone audiometers and impedance audiometers. These devices measure auditory function, middle-ear impedance, and vestibular responses, primarily for clinical use in audiological testing and evaluation.
Where is Amplivox, Ltd. based, and what does that mean for their regulatory compliance?
Amplivox, Ltd. is based in the United States. Since their devices are authorised under US regulatory frameworks, they are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. This ensures their products comply with US medical device regulations, including classification under FDA Class II.
How are Amplivox, Ltd.’s devices classified by regulatory authorities, and why?
Amplivox, Ltd.’s devices are classified as FDA Class II. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. Class II devices often require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Amplivox, Ltd.’s devices?
Amplivox, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure transparency and compliance with US medical device regulations, allowing healthcare providers and regulators to verify the authorised status of their products.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amplivox | Otowave 102 | FDA UDI | Class II | Active |
| Amplivox | Otowave 302 | FDA UDI | Class II | Active |
| Amplivox | Otowave 202 | FDA UDI | Class II | Active |
| Amplivox | Model 240 | FDA UDI | Class II | Active |
| Amplivox | Model 270 | FDA UDI | Class II | Active |
| Amplivox | PC850 | FDA UDI | Class II | Active |
| Amplivox | Otowave 302 | FDA UDI | Class II | Active |
| Amplivox | Model 170 | FDA UDI | Class II | Active |
| Amplivox | Otosure | FDA UDI | Class II | Active |
| Amplivox | Otowave 102-C | FDA UDI | Class II | Active |
| Amplivox | Model 116 | FDA UDI | Class II | Active |
| Amplivox | Otowave 302+ | FDA UDI | Class II | Active |
| Amplivox | Model 260 | FDA UDI | Class II | Active |
| Amplivox | Model 270+ | FDA UDI | Class II | Active |
| Amplivox | modelONE | FDA UDI | Class II | Active |
| Amplivox Otowave 102 Hand Held Portable Tympanometer | K081841 | FDA 510(k) | Class II | Active |
| Otowave 202 Portable Tympanometer | K150163 | FDA 510(k) | Class II | Active |
| Otowave 302 Portable Tympanometer | K171265 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Amplivox Ltd Birmingham · GB FEI 3003138182