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Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Wheelchair, power-assisted, occupant-controlled, collapsible FDA UDI
Device Name
WHEELCHAIR, VINYL, DLR, S/A, K2B, 18" FDA UDI
Model / Reference
MDS806250EV FDA UDI
Description
WHEELCHAIR, VINYL, DLR, S/A, K2B, 18" FDA UDI

Identifiers

Catalog Number
MDS806250EV FDA UDI
Primary DI / UDI-DI
00884389830041 FDA UDI
510(k) Number
K990463 FDA UDI
FDA Product Code
IOR FDA UDI
GMDN Term
Wheelchair, power-assisted, occupant-controlled, collapsible FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3850 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

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Push-rim manual wheelchair, non-bariatricWheelchair, power-assisted, occupant-controlled, collapsible

Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair, power-assisted, occupant-controlled, collapsible.

Cleared under the same submission

K990463 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 1c2efdde-9c50-404e-bdb9-270a92837f58 36 fields · synced May 30, 2026