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Scout

FDA UDI

Class II (US FDA UDI)

by Burke, Inc.

Identity

Trade Name
Scout FDA UDI
Generic Name
Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Device Name
Power Wheelchair FDA UDI
Model / Reference
RF4 FDA UDI
Description
Power Wheelchair FDA UDI

Identifiers

Catalog Number
81122 FDA UDI
Primary DI / UDI-DI
B314811221 FDA UDI
510(k) Number
K982158 FDA UDI
FDA Product Code
ITI FDA UDI
GMDN Term
Electric-motor-driven wheelchair, occupant-controlled FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electric-motor-driven wheelchair, occupant-controlled

Scout by Burke, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electric-motor-driven wheelchair, occupant-controlled.

Cleared under the same submission

K982158 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Burke, Inc.

Sources (1)

  • FDA UDI 94e652a0-de24-47b4-9156-29dfacf89c8b 35 fields · synced May 30, 2026