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WHILL (C2 +6 more)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 32-14016-1-04-2024-02-15

by WHILL, Inc.

Identity

Trade Name
WHILL, Inc. FDA UDI
Generic Name
Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Device Name
WHILL Model C2, WHILL Model F, WHILL Model FF, WHILL Model R 3-wheel, WHILL Model R 4-wheel, WHILL Autonomous Model B, WHILL Model C Lite EUDAMED
The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. FDA UDI
Model / Reference
32-14016-1-04-2024-02-15 EUDAMED
Model F FDA UDI
Description
The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. FDA UDI

Identifiers

Catalog Number
32-14016-1-04-2024-02-15 FDA UDI
Primary DI / UDI-DI
04570072301771 EUDAMED
04570072301832 FDA UDI
Basic UDI-DI
457007230PWDWheelchairXL EUDAMED
510(k) Number
K221438 FDA UDI
FDA Product Code
ITI FDA UDI
EMDN Code
Y122127 ELECTRIC WHEELCHAIRS EUDAMED
GMDN Term
Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Models / Variants
C2 EUDAMEDFDA UDI
WHILL Model F EUDAMEDFDA UDI
WHILL Model FF EUDAMEDFDA UDI
WHILL Model R 3-wheel EUDAMEDFDA UDI
WHILL Model R 4-wheel EUDAMEDFDA UDI
WHILL Autonomous Model B EUDAMEDFDA UDI
WHILL Model C Lite EUDAMEDFDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
890.3860 FDA UDI
Market of Registration
Spain EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

WHILL (C2 +6 more) by Whill, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 7 models — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
WHILL, Inc.
EUDAMED SRN
JP-MF-000016481
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

  • EUDAMED 0b932b66-af7c-4eb1-b091-abc22a9e08e3 61 fields · synced Oct 6, 2026
  • FDA UDI a6241a74-fcaf-401b-ae05-a803c085e02c 35 fields · synced May 30, 2026