BURKE, INC.

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

Vehicle, Motorized 3-Wheeled (INI) (9) Wheelchair, Powered (ITI) (1)

Premarket Exempt

No Yes

Clear

Scout - B313822501 Catalog Number : 82250

Device Description : Power Wheelchair

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

Pacesaver - B314150351 Catalog Number : 15035

Device Description : 3 wheeled scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150571 Catalog Number : 15057

Device Description : 3 wheeled scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150631 Catalog Number : 15063

Device Description : 3-Wheeled Scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150671 Catalog Number : 15067

Device Description : 3 wheeled Scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150681 Catalog Number : 15068

Device Description : 3 wheeled scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150701 Catalog Number : 15070

Device Description : 3 Wheeled scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150721 Catalog Number : 15072

Device Description : 4-Wheeled Scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150731 Catalog Number : 15073

Device Description : 4-Wheeled Scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

Pacesaver - B314150831 Catalog Number : 15083

Device Description : 3 Wheeled Scooter

Device Class : 2

Duns Number: 045093101

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

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