Lite-Med, Inc.
TaiwanFDA applicant, unverified
- Devices
- 3
What Lite-Med, Inc. makes
Lite-Med, Inc. manufactures lithotripters, specifically the LM-9300 ELMA Lithotripter, LM-9300 Plus Lithotripter, and the LITE-MED LM-9200 ELMA, which are devices used for extracorporeal shock wave therapy to fragment kidney stones.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. Lite-Med, Inc. is based in the United States.
Catalogue
LM-9300 ELMA Lithotripter Ref K142561
Regimes: 510(k) Registry: 510(k)LM-9300 Plus Lithotripter Ref K213772
Regimes: 510(k) Registry: 510(k)Lite-Med Lm-9200 Elma Ref K103217
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lite-Med, Inc. have in the registry?
The registry currently lists 3 devices for Lite-Med, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lite-Med, Inc.'s devices?
Among its 3 most recently registered devices, Lite-Med, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Lite-Med, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Lite-Med, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lite-Med, Inc. in the registry?
The most recently registered devices listed for Lite-Med, Inc. include LM-9300 ELMA Lithotripter, LM-9300 Plus Lithotripter and LITE-MED LM-9200 ELMA.