ELECTROMED, INC.

Address:502 SIXTH AVE. N.W.,NEW PRAGUE,MN,56071,US

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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

Percussor, Powered-Electric (BYI) (10)

Premarket Exempt

Clear

SmartVest - B102060078S0030 Catalog Number : SV-20-SS-GK

Device Description : LTU SmartVest® – Child S-Small (Ginkgo)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0040 Catalog Number : SV-20-SS-PK

Device Description : LTU SmartVest® – Child S-Small (Pink)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0050 Catalog Number : SV-20-SS

Device Description : LTU SmartVest® – Child S-Small (Teal)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0060 Catalog Number : SV-20-SS-YL

Device Description : LTU SmartVest® – Child S-Small (Yellow)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0070 Catalog Number : SV-20-SS-PP

Device Description : LTU SmartVest® – Child S-Small (Purple)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0080 Catalog Number : SV-20-SS-RD

Device Description : LTU SmartVest® – Child S-Small (Red)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0090 Catalog Number : SV-20-SS-BU

Device Description : LTU SmartVest® – Child S-Small (Blue)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0100 Catalog Number : SV-24-CS

Device Description : LTU SmartVest® – Child Small (Teal)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0110 Catalog Number : SV-24-CS-YL

Device Description : LTU SmartVest® – Child Small (Yellow)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0120 Catalog Number : SV-24-CS-PP

Device Description : LTU SmartVest® – Child Small (Purple)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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