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 - B102060078S0710 Catalog Number : SV-48-AX-YL

Device Description : LTU SmartVest® – Adult X-Large (Yellow)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0720 Catalog Number : SV-48-AX-PP

Device Description : LTU SmartVest® – Adult X-Large (Purple)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0730 Catalog Number : SV-48-AX-RD

Device Description : LTU SmartVest® – Adult X-Large (Red)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0740 Catalog Number : SV-48-AX-BU

Device Description : LTU SmartVest® – Adult X-Large (Blue)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0750 Catalog Number : SV-48-AX-PK

Device Description : LTU SmartVest® – Adult X-Large (Pink)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0760 Catalog Number : SV-48-AX-GK

Device Description : LTU SmartVest® – Adult X-Large (Ginkgo)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060145S0200 Catalog Number : SW-15/25-1

Device Description : SPU SmartVest Wrap® – S-Small

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060145S0300 Catalog Number : SW-17/25-1

Device Description : SPU SmartVest Wrap® – S-Small

Device Class :

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060145S0400 Catalog Number : SW-25/30-1

Device Description : SPU SmartVest Wrap® – Small

Device Class :

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060145S0500 Catalog Number : SW-30/36-1

Device Description : SPU SmartVest Wrap® – Medium

Device Class :

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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