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Burke, Inc.

US

Last updated May 30, 2026

What Burke, Inc. makes

Burke, Inc. makes electric-motor-driven wheelchairs that are occupant-controlled, assistive scooters that are electric-motor-driven, alternating-pressure bed mattress overlay systems, bariatric beds, and orthopaedic bed mattresses.

These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries; the company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Burke, Inc. manufacture?

Burke, Inc. produces electric-motor-driven wheelchairs that are occupant-controlled, assistive scooters that are electric-motor-driven, alternating-pressure bed mattress overlay systems, bariatric beds, and orthopaedic bed mattresses.

Where is Burke, Inc. based?

Burke, Inc. is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list Burke, Inc.'s devices?

Burke, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, as specified in the device data information.

How are Burke, Inc.'s medical devices classified?

Burke, Inc.'s devices are classified as Class I and Class II medical devices, which is indicated in the device data provided.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
913-722-5658
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
045093101

Catalogue (47)

DeviceModel / ReferenceRegistriesClassStatus
Pacesaver Plus III Premier
FDA UDI
Class IIActive
Scout M-1 350
FDA UDI
Class IIActive
Pacesaver Plus III Atlas
FDA UDI
Class IIActive
PaceSaver Fusion 250
FDA UDI
Class IIActive
Scout Boss 4.5 TPB
FDA UDI
Class IIActive
PaceSaver Espree Atlas 5
FDA UDI
Class IIActive
Burke Tri-Flex II
FDA UDI
Class IIActive
Pacesaver Plus III Junior
FDA UDI
Class IIActive
Scout RF 4-P
FDA UDI
Class IIActive
Scout M-1 TPB
FDA UDI
Class IIActive
Scout RF-P4 TPB-N
FDA UDI
Class IIActive
Pacesave Fusion 500
FDA UDI
Class IIActive
Scout Boss 6 TPB
FDA UDI
Class IIActive
Scout TPB
FDA UDI
Class IIActive
Scout Boss 4.5 N/S
FDA UDI
Class IIActive
Pacesaver Espree Titan
FDA UDI
Class IIActive
Pacesaver Espree' Premier
FDA UDI
Class IIActive
Scout RF-P4
FDA UDI
Class IIActive
Scout RF-P4 W/S
FDA UDI
Class IIActive
Burke Bari-Float Mattress 54"
FDA UDI
Class IActive
Scout RF4
FDA UDI
Class IIActive
Pacesaver Fusion 450
FDA UDI
Class IIActive
Burke Bari-Float Mattress 48"
FDA UDI
Class IActive
Scout Boss 6
FDA UDI
Class IIActive
Scout Boss 6NS TPB
FDA UDI
Class IIActive
Scout 4 P
FDA UDI
Class IIActive
Pacesaver Espree Atlas
FDA UDI
Class IIActive
Scout RF - SP
FDA UDI
Class IIActive
Scout Boss 6.75 TPB
FDA UDI
Class IIActive
Pacesaver Eclipse Atlas 5
FDA UDI
Class IIActive
Scout Boss 6.75
FDA UDI
Class IIActive
Pacesaver Eclipse Atlas
FDA UDI
Class IIActive
Pacesaver Eclipse Premier
FDA UDI
Class IIActive
Scout RF-P4 TPB-S
FDA UDI
Class IIActive
Burke Inc Tri-Flex Air
FDA UDI
Class IIActive
Scout Boss 6NS
FDA UDI
Class IIActive
Pacesaver Fusion 350
FDA UDI
Class IIActive
Pacesaver Plus III Titan
FDA UDI
Class IIActive
Scout M-1
FDA UDI
Class IIActive
PS Scout RF TPB
FDA UDI
Class IIActive
Fusion K061912
FDA 510(k)
Class IIActive
Pacesaver & Scout K834506
FDA 510(k)
Class IIActive
Concept Model 5200 Thermal Therapy System K911943
FDA 510(k)
Class IIActive
Scout Boss K023961
FDA 510(k)
Class IIActive
Pace Saver, Little Junior (modification)(motorized Three-Wheeled Vehicle) K965123
FDA 510(k)
Class IIActive
Scout K982158
FDA 510(k)
Class IIActive
Cold/Hot Fluid Radiation Pad Neutech K893706
FDA 510(k)
Class IIActive

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