Tyece, Ltd.
Country not established FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Tyece, Ltd. makes
Tyece, Ltd. manufactures transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices designed for over-the-counter (OTC) use. These include portable TENS units and EMS systems, such as the TENS Model and EMS System Model EM35, intended for pain relief and muscle stimulation.
The company’s products are classified as Class II medical devices under U.S. regulations and are listed via the FDA’s 510(k) pathway. These devices are registered in the U.S. and comply with applicable FDA requirements for non-prescription electrical stimulation equipment.
Catalogue
Tyece OTC TENS Model Ref K200838
510(k) 510(k)Tyece OTC EMS System Ref K183454
510(k) 510(k)Tyece OTC TENS Device Ref K150386
510(k) 510(k)Tyece OTC EMS System, Model EM35 Ref K172241
510(k) 510(k)
FDA establishments
- Tyece Limited Kowloon · HK FEI 3007092044
Frequently asked questions
How many devices does Tyece, Ltd. have in the registry?
The registry currently lists 4 devices for Tyece, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tyece, Ltd.'s devices?
Among its 4 most recently registered devices, Tyece, Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Tyece, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Tyece, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tyece, Ltd. in the registry?
The most recently registered devices listed for Tyece, Ltd. include Tyece OTC TENS Model, Tyece OTC EMS System, Tyece OTC TENS Device and Tyece OTC EMS System, Model EM35.
Which FDA establishments are linked to Tyece, Ltd.?
1 FDA establishment is linked to Tyece, Ltd. in the registry; they are listed on the company page.