ELECTROMED, INC.

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

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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) (3)

Premarket Exempt

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SmartVest - B102090740S8400 Catalog Number : SQL-USA-W

Device Description : SQL-W Supplement Kit (USA)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090766S0100 Catalog Number : SQL-FOOT-KIT

Device Description : SQL® Replacement Foot Kit

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B10209488S1510 Catalog Number : SQL_R-W-RD

Device Description : Refurb SQL® SmartVest®, Wireless (Red)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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