FDA.reportPublic FDA data

SLEEPING WELL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087979263008797926SLEEPING WELL, LLC1N2026-01-01138 Steeplebush Rd. Shelburne VT US 05482

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1243491379105667K213088ZQuiet AdvanceLRK2022-06-15
1243491507500816K180124ZQuietLRK2018-06-12
1243491931009698K140777ZQUIET-SALRK2014-07-25
1243491739184952K122475ZQUIET PRO-PLUSLRK2012-12-07
1243491618645139K093407ZQUIET MOUTHPIECELRK2010-06-22
1243491549675619K090503ZQUIET MOUTHPIECELRK2009-03-10
1243491344954540K040491CHIN-UP STRIPLWF2004-09-10
1243491946829302
1243492011949052

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK62022-06-15
LWF12004-09-10

PMN#

ZQuiet

2018-06-12

Sleeping Well,LLC

GUDID#