Sxwell USA, LLC
United StatesFDA applicant, unverified FDA FEI 3013388459
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Sxwell USA, LLC makes
Sxwell USA, LLC manufactures barrier contraceptives, including synthetic polyisoprene lubricated male condoms designed for sensory experience, and personal lubricants intended for intimate use.
These products fall under FDA Class II regulation and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3013388459
- Address
- 66 Hudson Blvd E, 24th Floor, New York, NY, 10001
Frequently asked questions
How many devices does Sxwell USA, LLC have in the registry?
The registry currently lists 2 devices for Sxwell USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sxwell USA, LLC's devices?
Among its 2 most recently registered devices, Sxwell USA, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Sxwell USA, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sxwell USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sxwell USA, LLC in the registry?
The most recently registered devices listed for Sxwell USA, LLC include Synthetic Polyisoprene Lubricated Male Condom - 5 senses and LifeStyles® SKYN® Intimate Moments Personal Lubricant.