FDA.reportPublic FDA data

Freespira, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108876383010887638Freespira, Inc1N2026-01-0112020 113th Ave NE Ste 215 Kirkland WA US 98034

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
B185FS059370FST5 - Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.18007358995par@freespira.com
B185SM40500Freespira - Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.800-735-8995par@freespira.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1712891293877439K233337Freespira Breathing SystemSEN2025-04-24
1712891699504106K180173FreespiraHCC2018-08-23
1712891357667858K131586CANARY BREATHING SYSTEMHCC2013-12-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HCC22018-08-23
SEN12025-04-24

GUDID#