FDA.reportPublic FDA data

BIG HEALTH INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30244423503024442350BIG HEALTH INC1N2026-01-012067 Port Bristol Cir Newport Beach CA US 92660

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860008033024SleepioRx - SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.(707) 563-1049hello@bighealth.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3195261941291629K233872DaylightSCP2024-08-30
3195261494673825K233577Sleepio®QVO2024-08-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SCP12024-08-30
QVO12024-08-05

PMN#

GUDID#