Rockwin Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Rockwin Corp. makes
Rockwin Corp. manufactures a range of hearing aids, including rechargeable and non-rechargeable models such as the HB-36M, HB-36MS, and HI-67P, as well as the EXCEL-1000 series. Additional products include the HI-69E, HI-69N, and HI-69P, along with the RIONET HM-02, a wireless connectivity device for hearing aid users.
These devices are classified under Class I by the FDA and have undergone 510(k) clearance. The company is based in the United States, and its products are listed in the FDA’s regulatory database.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Hi-69E, Hi-69N, Hi-69P Ref K974129
Regimes: 510(k) Registry: 510(k)Rionet Hm-02 Ref K943808
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rockwin Corp. have in the registry?
The registry currently lists 3 devices for Rockwin Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rockwin Corp.'s devices?
Among its 3 most recently registered devices, Rockwin Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Rockwin Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Rockwin Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Rockwin Corp. in the registry?
The most recently registered devices listed for Rockwin Corp. include HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000, HI-69E, HI-69N, HI-69P and RIONET HM-02.