Spark Innovators Corporation

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Filters

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

Massager, Therapeutic, Electric (ISA) (1) Pad, Heating, Powered (IRT) (1)

Premarket Exempt

Yes

Clear

Sting Doctor - 00850018026109 Catalog Number :

Device Description : The Sting Doctor is a handheld, battery powered device that uses targeted heat t The Sting Doctor is a handheld, battery powered device that uses targeted heat therapy intended to help reduce the itch and irritation caused by insect bites/stings from mosquitoes, bees, and wasps.

Device Class : 2

Duns Number: 831838391

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Comfy Curve Massage Pro - 00850018026161 Catalog Number :

Device Description : The Comfy Curve Massage Pro device is an electrically powered, vibrating therape The Comfy Curve Massage Pro device is an electrically powered, vibrating therapeutic massager. The device consists of a memory foam pillow with a small internal motor, powered by (2) AA batteries (not included), that vibrates the entire pillow. The Comfy Curve Massage Pro is an OTC device that is intended to be used on the body for relief of minor aches and pains.

Device Class : 1

Duns Number: 831838391

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

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