Wellpower Sporting Goods Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3007942528
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Wellpower Sporting Goods Co., Ltd. makes
Wellpower Sporting Goods Co., Ltd. manufactures the Phyziofit Medical Surgical Mask, a disposable barrier device designed for medical use to reduce exposure to airborne pathogens during procedures or patient care.
The Phyziofit Medical Surgical Mask is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Phyziofit Medical Surgical Mask Ref K201868
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3007942528
- Address
- No.62 Liaobu Xinglong Street,, Dong Guan Guangdong
Frequently asked questions
How many devices does Wellpower Sporting Goods Co., Ltd. have in the registry?
The registry currently lists 1 device for Wellpower Sporting Goods Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wellpower Sporting Goods Co., Ltd.'s devices?
Among its 1 most recently registered device, Wellpower Sporting Goods Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Wellpower Sporting Goods Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Wellpower Sporting Goods Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wellpower Sporting Goods Co., Ltd. in the registry?
The most recently registered devices listed for Wellpower Sporting Goods Co., Ltd. include Phyziofit Medical Surgical Mask.