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 - B102060078S0130 Catalog Number : SV-24-CS-RD

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0140 Catalog Number : SV-24-CS-BU

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0150 Catalog Number : SV-24-CS-PK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0160 Catalog Number : SV-24-CS-GK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0200 Catalog Number : SV-28-CM

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0210 Catalog Number : SV-28-CM-YL

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0220 Catalog Number : SV-28-CM-PP

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0230 Catalog Number : SV-28-CM-RD

Device Description : LTU SmartVest® – Child Medium (Red)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0240 Catalog Number : SV-28-CM-BU

Device Description : LTU SmartVest® – Child Medium (Blue)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0250 Catalog Number : SV-28-CM-PK

Device Description : LTU SmartVest® – Child Medium (Pink)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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