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Specification
BatteriesRequired : 1
Brand : AIMQFFF
BulletPoint1 : Both the subiect and predicate devices are indicated for Over-the-Counter (OTc) use in alleviating snoring for adults 18 and older by wayofmandibular repositioning.
BulletPoint2 : The device is intended to be used by lay users in a nonclinical environment for over-the-counter use.
BulletPoint3 : The device is intended to aid in the reduction of snoring for adults at least 18 years old.
BulletPoint4 : Backed by science and years of testing, keeps your airway open while you sleep, by holding your lower jaw forward, stopping your jaw from pinching your airway.
BulletPoint5 : 【Quiet Operation】: Our Nebulizer are designed with noise reduction technology for quiet operation, generating less than 25dB noise during work, providing a peaceful and comfortable experience during administration, ensuring convenient and hassle-free.
Color : Whitegreen
ExternallyAssignedProductIdentifier1 : 0889563750528
ExternallyAssignedProductIdentifier2 : 889563750528
FdaDeviceClassification : ii
FdaIndicationOfUse : otc
FdaInstructionsForUseType : consumer
FdaLabelType : consumer
FdaPremarketApprovalNumber510k : K231138
FdaPremarketApprovalNumberPma : K231138
Hazmat1 : LITHIUM ION BATTERIES CONTAINED IN EQUIPMENT
Hazmat10 : DE_SmallLithiumIonBatteryInEquipment
Hazmat11 : EG_SmallLithiumIonBatteryInEquipment
Hazmat12 : ES_SmallLithiumIonBatteryInEquipment
Hazmat13 : FR_SmallLithiumIonBatteryInEquipment
Hazmat14 : GB_SmallLithiumIonBatteryInEquipment
Hazmat15 : IN_SmallLithiumIonBatteryInEquipment
Hazmat16 : IT_SmallLithiumIonBatteryInEquipment
Hazmat17 : JP_SmallLithiumIonBatteryInEquipment
Hazmat18 : MX_SmallLithiumIonBatteryInEquipment
Hazmat19 : NL_SmallLithiumIonBatteryInEquipment
Hazmat2 : UN3481
Hazmat20 : PL_SmallLithiumIonBatteryInEquipment
Hazmat21 : SA_SmallLithiumIonBatteryInEquipment
Hazmat22 : SE_SmallLithiumIonBatteryInEquipment
Hazmat23 : SG_SmallLithiumIonBatteryInEquipment
Hazmat24 : TR_SmallLithiumIonBatteryInEquipment
Hazmat25 : US_SmallLithiumIonBatteryInEquipment
Hazmat26 : ZA_SmallLithiumIonBatteryInEquipment
Hazmat27 : 9
Hazmat28 : 9
Hazmat3 : II
Hazmat4 : AE_SmallLithiumIonBatteryInEquipment
Hazmat5 : AU_SmallLithiumIonBatteryInEquipment
Hazmat6 : BE_SmallLithiumIonBatteryInEquipment
Hazmat7 : BR_SmallLithiumIonBatteryInEquipment
Hazmat8 : CA_SmallLithiumIonBatteryInEquipment
Hazmat9 : CN_SmallLithiumIonBatteryInEquipment
IncludedComponents : nebulizer
ItemName : AIMQFFF Anti-Snore Mouthguard+
ItemPackageDimensions_Height : 1 inches
ItemPackageDimensions_Length : 3 inches
ItemPackageDimensions_Width : 2 inches
ItemPackageQuantity : 1
ItemTypeKeyword : professional-medical-nebulizers
Manufacturer : AIMQFFF
NumberOfBoxes : 1
NumberOfItems : 1
PartNumber : 017
ProductDescription : The device is intended to aid in the reduction of snoring for adults at least 18 years old.
ProductSiteLaunchDate : 2024-05-23T12:55:59.986Z
Size : WH-A-11
SupplierDeclaredDgHzRegulation : not_applicable
TemperatureRating : Ambient: 15 to 25 C (59 to 77 F)
UnitCount : 1