FDA.reportPublic FDA data

Isabel Restivo

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050191843005019184Isabel Restivo1N2026-01-01101 Wood Avenue South 7th Floor Iselin NJ US 08830
30132943113013294311Isabel Restivo1N2026-01-01101 wood avenue south 7th Floor Iselin NJ US 08830
30199180543019918054Isabel Restivo1N2026-01-01101 Wood Ave S Ste 7 Iselin NJ US 08830

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
753851363011016K233464WSA Self-Fitting Hearing Aid Gen 2QUH2024-02-09
753851019481203K220403Vibe SF Self-Fitting Hearing AidQDD2022-08-12
2950711526593874K220403Vibe SF Self-Fitting Hearing AidQDD2022-08-12
753851091299809K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)ETW2007-06-05
753851664460054K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)KLW2001-06-01
2201281803908232K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)KLW2001-06-01
2201281368489309
753851580040694
2201281771711039
2201281012298289
2950711107435351
2950711201261397
2201281349381985
753851382013727
2950711484437819
753851511402778
2950711730328077
2201281803908232

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QDD22022-08-12
KLW22001-06-01
QUH12024-02-09
ETW12007-06-05