FDA.reportPublic FDA data

Earflo Company

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30437396463043739646Earflo Company1N2026-01-01203 Lothrop St Suite 500 Pittsburgh PA US 15213

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
00860014369506Earflo - Earflo is a rechargeable, hand-held therapeutic device designed to provide treatment of negative middleear pressure through a non-invasive method. Earflo functions by delivering controlled pressurized airinto the nasal passages to ventilate the middle ear by momentarily increasing the air pressure in the noseand eustachian tubes. During use, the child drinks from the integrated sippy cup while the nose is sealedagainst the device’s mask. When liquid is swallowed, a puff of air is delivered into the nasal passageand eustachian tube, thereby opening the eustachian tube and equalizing pressure in the middle ear.Earflo is intended for use in children aged two years and older (under adult supervision) and adults torelieve negative middle ear pressure, prevent the accumulation of middle ear fluid, and prevent hearingloss.8054527453help@earflocare.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3492731010205730K252751Earflo (EF001)MJV2026-02-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MJV12026-02-10

GUDID#

Earflo - Earflo is a rechargeable, hand-held therapeutic device designed to provide treatment of negative middleear pressure through a non-invasive method. Earflo functions by delivering controlled pressurized airinto the nasal passages to ventilate the middle ear by momentarily increasing the air pressure in the noseand eustachian tubes. During use, the child drinks from the integrated sippy cup while the nose is sealedagainst the device’s mask. When liquid is swallowed, a puff of air is delivered into the nasal passageand eustachian tube, thereby opening the eustachian tube and equalizing pressure in the middle ear.Earflo is intended for use in children aged two years and older (under adult supervision) and adults torelieve negative middle ear pressure, prevent the accumulation of middle ear fluid, and prevent hearingloss.

EARFLO, INC.

2026-03-31