Amplivox, Ltd.
US Last updated 23 May 2026
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- Devices
- 18
- Registries
- EUDAMEDGUDIDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Amplivox Otowave 102 Ref Otowave 102
Amplivox Otowave 302 Ref Otowave 302
Amplivox Otowave 202 Ref Otowave 202
Amplivox Model 240 Ref Model 240
Amplivox Model 270 Ref Model 270
Amplivox PC850 Ref PC850
Amplivox Otowave 302 Ref Otowave 302
Amplivox Model 170 Ref Model 170
Amplivox Otosure Ref Otosure
Amplivox Otowave 102-C Ref Otowave 102-C
Amplivox Model 116 Ref Model 116
Amplivox Otowave 302+ Ref Otowave 302+
Amplivox Model 260 Ref Model 260
Amplivox Model 270+ Ref Model 270+
Amplivox modelONE Ref modelONE
Otowave 202 Portable Tympanometer Ref K150163
Otowave 302 Portable Tympanometer Ref K171265
FDA establishments
- Amplivox Ltd Birmingham · GB FEI 3003138182
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.
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.
Information
- Country
- US