Henley Healthcare, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Henley Healthcare, Inc. makes
Henley Healthcare manufactures ultrasound-based lithotripsy systems, including the ENRAF-NONIUS Sonopuls 190 System for extracorporeal shockwave therapy and the ENRAF-NONIUS Endomed 182 System for ureteral stone treatment. These devices are designed to fragment kidney and urinary stones using focused acoustic energy.
The company’s products fall under Class II regulatory classification in the US and are listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Enraf-Nonius Sonopuls 190 System Ref K000084
Regimes: 510(k) Registry: 510(k)Enraf-Nonius Endomed 182 System Ref K003744
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Henley Healthcare, Inc. have in the registry?
The registry currently lists 2 devices for Henley Healthcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Henley Healthcare, Inc.'s devices?
Among its 2 most recently registered devices, Henley Healthcare, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Henley Healthcare, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Henley Healthcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Henley Healthcare, Inc. in the registry?
The most recently registered devices listed for Henley Healthcare, Inc. include ENRAF-NONIUS SONOPULS 190 SYSTEM and ENRAF-NONIUS ENDOMED 182 SYSTEM.