BURKE, INC.

Address:1800 MERRIAM LN.,KANSAS CITY,KS,66106,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

Wheelchair, Powered (ITI) (10)

Premarket Exempt

No Yes

Clear

Scout - B31481113A1 Catalog Number : 81113A

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B314811221 Catalog Number : 81122

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B31481445A1 Catalog Number : 81445A

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B31481855A1 Catalog Number : 81855A

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B314820621 Catalog Number : 82062

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B314823061 Catalog Number : 82306

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B314823381 Catalog Number : 82338

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B314823481 Catalog Number : 82348

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B314823891 Catalog Number : 82389

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Scout - B314824911 Catalog Number : 82491

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

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