R82

FDA UDI

Class I (US FDA UDI)

by R82 A/S

Identity

Trade Name: R82 FDA UDI
Generic Name: Push-rim manual wheelchair, non-bariatric FDA UDI
Model / Reference: Kudu SIZE-2 FDA UDI

Identifiers

Catalog Number: 95221116111 FDA UDI
Primary DI / UDI-DI: 05707292831071 FDA UDI
510(k) Number: K151492 FDA UDI
FDA Product Code: IOR FDA UDI
GMDN Term: Push-rim manual 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Push-rim manual wheelchair, non-bariatric

R82 by R82 A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Push-rim manual wheelchair, non-bariatric.

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Probasics — COMPASS HEALTH BRANDS CORP. · Class I
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DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
Probasics — COMPASS HEALTH BRANDS CORP. · Class I
RoughRider — ROUGHRIDER AMERICA LLC · Class I
JUDITTA — ORMESA SRL · Class I

Cleared under the same submission

K151492 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: R82 A/S

Sources (1)

FDA UDI 24943e65-85f8-4371-8719-70d289e7176a 34 fields · synced May 30, 2026