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FDA UDI

Class I (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
drive FDA UDI
Generic Name
Attendant-only-propelled wheelchair, non-bariatric FDA UDI
Device Name
Transport chairs/Wheelchairs Wheelchairs K4 Product Description ViperPlsGT,20"FlpBk.UniArm,ELR,1/ea FDA UDI
Model / Reference
PLA420FBUARAD-ELR FDA UDI
Description
Transport chairs/Wheelchairs Wheelchairs K4 Product Description ViperPlsGT,20"FlpBk.UniArm,ELR,1/ea FDA UDI

Identifiers

Primary DI / UDI-DI
00822383005300 FDA UDI
510(k) Number
K181795 FDA UDI
FDA Product Code
IOR FDA UDI
GMDN Term
Attendant-only-propelled wheelchair, non-bariatric 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Attendant-only-propelled wheelchair, non-bariatric

drive by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Attendant-only-propelled wheelchair, non-bariatric.

Cleared under the same submission

K181795 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drive Devilbiss Healthcare

Sources (1)

  • FDA UDI 375a2404-e796-4cf4-818c-96e6217f3260 34 fields · synced Jun 8, 2026