Penn-Tech Laboratories
Country not established
- Devices
- 1
What Penn-Tech Laboratories makes
Penn-Tech Laboratories manufactures custom-fit hearing aids designed for use in the ear, specifically all-in-the-ear (AITE) and all-in-the-canal (AITC) styles. These devices are tailored for discreet, in-canal placement to address mild to moderate hearing loss.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. These devices are regulated under US jurisdiction and comply with FDA requirements for hearing aids. The manufacturer is based in the United States.
Catalogue
Hearing Aid(All In The Ear(All In The Canal Ref K852052
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Penn-Tech Laboratories have in the registry?
The registry currently lists 1 device for Penn-Tech Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Penn-Tech Laboratories's devices?
Among its 1 most recently registered device, Penn-Tech Laboratories has devices listed in FDA 510(k) (1 device).
What risk classes do Penn-Tech Laboratories's devices fall under?
Among its 1 most recently registered device, the classes recorded for Penn-Tech Laboratories's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Penn-Tech Laboratories in the registry?
The most recently registered devices listed for Penn-Tech Laboratories include HEARING AID(ALL IN THE EAR(ALL IN THE CANAL.