Dcstar, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dcstar, Inc. makes
Dcstar, Inc. manufactures full-face sleep apnea breathing therapy masks, including the JoyMask 20-B and JoyMask 21-B, as well as mandibular advancement devices such as the L07 model. These products are designed for continuous positive airway pressure (CPAP) therapy and oral appliance treatment for obstructive sleep apnea.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States, where Dcstar, Inc. is based.
Catalogue
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask Ref K251920
Regimes: 510(k) Registry: 510(k)Mandibular Advancement Device L07 Ref K251628
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dcstar, Inc. have in the registry?
The registry currently lists 2 devices for Dcstar, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dcstar, Inc.'s devices?
Among its 2 most recently registered devices, Dcstar, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dcstar, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dcstar, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dcstar, Inc. in the registry?
The most recently registered devices listed for Dcstar, Inc. include Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask and Mandibular Advancement Device L07.