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 - B102060078S0260 Catalog Number : SV-28-CM-GK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0300 Catalog Number : SV-32-CL

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0310 Catalog Number : SV-32-CL-YL

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0320 Catalog Number : SV-32-CL-PP

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0330 Catalog Number : SV-32-CL-RD

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0340 Catalog Number : SV-32-CL-BU

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0350 Catalog Number : SV-32-CL-PK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0360 Catalog Number : SV-32-CL-GK

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0400 Catalog Number : SV-36-AS

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102060078S0410 Catalog Number : SV-36-AS-YL

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

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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