Data / Medical devices / Hong Kong / Tyece Limited
Tyece Limited: FDA-registered device maker in Kowloon, Hong Kong, 6 510(k) clearances
Tyece Limited is registered with the FDA (registration 3007092044) in Kowloon, Hong Kong. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 12, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007092044
- Address
- Unit 803, Block A, Po Lung Centre 11 Wang Chiu Rd, Kowloon Bay, Kowloon, Hong Kong, HKG
- Owner or operator
- Tyece Limited (10031685)
- Roles
- Specification developer
- First device listed
- February 25, 2010
- Registered through
- 2026
- Brand names listed
- ELC, TENS/EMS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detectors And Removers, Lice, (Including Combs) | LJL | 1 | Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 12, 2020 | K200838 | Tyece OTC TENS Model | NUH | Substantially Equivalent | Tyece Limited | accessdata.fda.gov |
| February 26, 2019 | K183454 | Tyece OTC EMS System | NGX | Substantially Equivalent | Tyece , Ltd. | accessdata.fda.gov |
| November 20, 2017 | K172241 | Tyece OTC EMS System, Model EM35 | NGX | Substantially Equivalent | Tyece , Ltd. | accessdata.fda.gov |
| November 5, 2015 | K150386 | Tyece OTC TENS Device | NUH | Substantially Equivalent | Tyece , Ltd. | accessdata.fda.gov |
| September 4, 2012 | K113321 | TENS BACK PAIN RELIEF SYSTEM | NUH | Substantially Equivalent | Savia Limited | accessdata.fda.gov |
| January 7, 2004 | K032003 | PREMIER PLUS | GZJ | Substantially Equivalent | American Imex | 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
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Detectors And Removers, Lice, (Including Combs)
Updated August 12, 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.