Lehigh Group
Country not established
- Devices
- 1
What Lehigh Group makes
Lehigh Group manufactures the IMPAX, a device designed as a male impotence aid intended for use in addressing erectile dysfunction.
The IMPAX falls under FDA Class II regulation and is listed in the 510(k) clearance registry. The company is based in the United States.
Catalogue
Impax, Male Impotence Aid Ref K861468
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lehigh Group have in the registry?
The registry currently lists 1 device for Lehigh Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lehigh Group's devices?
Among its 1 most recently registered device, Lehigh Group has devices listed in FDA 510(k) (1 device).
What risk classes do Lehigh Group's devices fall under?
Among its 1 most recently registered device, the classes recorded for Lehigh Group's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lehigh Group in the registry?
The most recently registered devices listed for Lehigh Group include IMPAX, MALE IMPOTENCE AID.