Earflo

Primary DI
00860014369506
Brand
Earflo
Company
EARFLO, INC.
Model
EF001
Device description
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.
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJVDevice, Inflation, Middle Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJVDevice, Inflation, Middle EarUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252751000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252751000Earflo (EF001)Earflo, Inc.2026-02-10MJV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014369506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014369506008600143695068600143695060860014369506

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear decompressor, positive pressureA manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height165Millimeter
Outer Diameter72Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
8054527453help@earflocare.com

Regulatory Flags#

DUNS number
138345369
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00705928603691NeilMed EustachiNEILMED PHARMACEUTICALS, INC.MJV2026-04-27
06971919466949noneNingbo Albert Novosino Co.,Ltd.MJV2023-10-26
00385640002431NASummit Medical, Inc.MJV2021-05-18
00385640002424InstrusafeSummit Medical, Inc.MJV2016-10-11
00385640023849NASummit Medical, Inc.MJV2016-10-11
00385640023863NASummit Medical, Inc.MJV2016-10-11
00385640023870NASummit Medical, Inc.MJV2016-10-11