Insound Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Insound Medical, Inc. makes
Insound Medical, Inc. manufactures hearing aids, specifically the INSOUND XT SERIES HEARING AID and LYRIC HEARING AID.
The company's devices are Class I and listed in the FDA 510(k) registry. Insound Medical is based in the US.
Catalogue
Insound Xt Series Hearing Aid Ref K021867
Regimes: 510(k) Registry: 510(k)Lyric Hearing Aid Ref K081136
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Insound Medical, Inc., initiated on 2010-01-19. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 19 Jan 2010 Z-1681-2010 Unclassified (pre-2012) Terminated Manufacturing error could result in electrolyte leakage from the product's battery.
Frequently asked questions
How many devices does Insound Medical, Inc. have in the registry?
The registry currently lists 2 devices for Insound Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insound Medical, Inc.'s devices?
Among its 2 most recently registered devices, Insound Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Insound Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Insound Medical, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Insound Medical, Inc.?
FDA recall records list 1 recall initiated by Insound Medical, Inc., the most recent initiated on 19 Jan 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Insound Medical, Inc. in the registry?
The most recently registered devices listed for Insound Medical, Inc. include INSOUND XT SERIES HEARING AID and LYRIC HEARING AID.