HOME AIDE DIAGNOSTICS, INC.

Address:1072 S Powerline Rd,Deerfield Bch,FL,33442,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mouthpiece, Saliva Ejector (DYN) (2) Lancet, Blood (FMK) (2) Nebulizer (Direct Patient Interface) (CAF) (1) Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (CCQ) (1) Pad, Alcohol, Device Disinfectant (LKB) (1) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (1) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (1) Bedding, Disposable, Medical (KME) (1) Thermometer, Electronic, Clinical (FLL) (1) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

No Yes

Clear

Pro Comfort TENS Unit - 00850632007188 Catalog Number : 7188

Device Description : Features:1.LCD screen2.2 output ports3.10-60 minutes adjustable4.Rechargeable bu Features:1.LCD screen2.2 output ports3.10-60 minutes adjustable4.Rechargeable built-in lithium batteryFunctions:1.Eliminate body fatigue2.Relax muscles and joints3.Improve blood circulation4.Increase metabolism and preventmany work related symptomsSpecifications1.Power/voltage: 3.7V2.Massage issuing frequency: 1~110Hz3.Consumed current: 40mA4.Status adjustment: 6 kinds of status

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : NGX, GZJ

Prescription Use : Yes

Device Count : 1

Pro Comfort Tens Unit Pads - 00850632007218 Catalog Number : 7218

Device Description : 2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens UnitT 2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens UnitThe life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following the instructions for use found in the manual. The expired electrodes are to be recycled and do not harm the environment.

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : GXY, NUH

Prescription Use : Yes

Device Count : 1

Easy Neb - 00850632007225 Catalog Number : 7225

Device Description : Easy Neb Compressor Nebulizer Suitable for all ages

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

SAPS health Incontinence Underpads - 00850632007232 Catalog Number :

Device Description : • 150 underpads per box• Size: 30in x 36in• 28" wide pad• 60 grams of paddin • 150 underpads per box• Size: 30in x 36in• 28" wide pad• 60 grams of padding• 24" of padded protection• Extra absorbent underpads for incontinence• Provides excellent protection for beds and chairs• Absorbs well to prevent leakage• Reduces odors and maintains dryness

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 1

Pro Comfort Inhaler Space Chamber w/ ADULT mask - 00850632007270 Catalog Number : 7270

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : DYN, CCQ

Prescription Use : No

Device Count : 1

Pro Comfort Inhaler Space Chamber w/ CHILD mask - 00850632007287 Catalog Number : 7287

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 1

Easy Comfort Twist Top Lancets 30G - 00850632007317 Catalog Number :

Device Description : • 50 sterile tip lancets per box• 30 Gauge• Twist top lancets• Single use• • 50 sterile tip lancets per box• 30 Gauge• Twist top lancets• Single use• Provides virtually painless testing• Comfort depth penetration• Smooth tri-bevel point

Device Class : 2

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

SAPS Healthcare Twist Top lancets 30G - 00850632007324 Catalog Number :

Device Description : • 30 Gauge• Twist top lancets• Single use• Provides virtually painless testi • 30 Gauge• Twist top lancets• Single use• Provides virtually painless testing• Comfort depth penetration• Smooth tri-bevel point• 100 sterile tip lancets per box

Device Class : 2

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

SAPS health care Alcohol Pads - 00850632007331 Catalog Number :

Device Description : • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed a • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed alcohol pads per box• For external use only

Device Class : U

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : LKB

Prescription Use : No

Device Count : 1

Pro Comfort Tempa Check 4-in-1 Infrared thermometer - 00850632007348 Catalog Number :

Device Description : Medical thermometer for measuring ear/ forehead/ object temperature/ ambient tem Medical thermometer for measuring ear/ forehead/ object temperature/ ambient temperature of human body via infrared rays emitted from the eardrum and skin surface. Measuring range: 32.0-42.9°C (89.6-109.2°F)

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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