Data / Medical devices / Hong Kong / Hongkong Shared Dream Enterprise Limited
Hongkong Shared Dream Enterprise Limited: FDA-registered device maker in Kowloon, Hong Kong, 2 510(k) clearances
Hongkong Shared Dream Enterprise Limited is registered with the FDA (registration 3012500350) in Kowloon, Hong Kong. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 11, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012500350
- Address
- 19H Maxgrand Plaza No.3 Tai Yau Street San Po Kong, Kowloon, Hong Kong, 999077
- Owner or operator
- HONGKONG SHARED DREAM ENTERPRISE LIMITED (10060705)
- Roles
- Exporter to the US
- First device listed
- June 13, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2020 | K201354 | TENS & PMS | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| May 10, 2013 | K121719 | SM TENS & PMS | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated December 11, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.