Safte S.p.A.
ItalyFDA applicant, unverified
- Devices
- 1
What Safte S.p.A. makes
Safte S.P.A. manufactures hernia support belts, including models numbered 316, 515, and 536, designed to provide external compression for abdominal or inguinal hernia management.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Safte Orione Hernia Belt Items No. 316, 515, 536 Ref K901922
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Safte S.P.A. have in the registry?
The registry currently lists 1 device for Safte S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safte S.P.A.'s devices?
Among its 1 most recently registered device, Safte S.P.A. has devices listed in FDA 510(k) (1 device).
What risk classes do Safte S.P.A.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Safte S.P.A.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Safte S.P.A. in the registry?
The most recently registered devices listed for Safte S.P.A. include SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536.