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

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

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

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•

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

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

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

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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