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 - B102060078S0550 Catalog Number : SV-40-AM-PK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0560 Catalog Number : SV-40-AM-GK

Device Description : LTU SmartVest® – Adult Medium (Ginkgo)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0600 Catalog Number : SV-44-AL

Device Description : LTU SmartVest® – Adult Large (Teal)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0610 Catalog Number : SV-44-AL-YL

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0620 Catalog Number : SV-44-AL-PP

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0630 Catalog Number : SV-44-AL-RD

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0640 Catalog Number : SV-44-AL-BU

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0650 Catalog Number : SV-44-AL-PK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0660 Catalog Number : SV-44-AL-GK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0700 Catalog Number : SV-48-AX

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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