FDA.reportPublic FDA data

SXWELL USA LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30133884593013388459SXWELL USA LLC1Y2026-01-0166 Hudson Blvd E, 24th Floor New York NY US 10001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2111011691919169K230674JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114NUC2023-05-08
2111011710690071K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal LubricantNUC2019-03-04
2111011217160251K180083Silicone Personal Lubricant, ALL-IN-ONENUC2018-04-09
2111011274925423K172447JO Gelato Flavored Personal LubricantsNUC2017-10-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUC42023-05-08

PMN#