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ComfyGO

FDA UDI

Class II (US FDA UDI)

by ComfyGO, Inc

Identity

Trade Name
ComfyGO FDA UDI
Generic Name
Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Device Name
Lightweight carbon fiber electric wheelchair with foldable frame, airline-approved lithium battery, and joystick controller. Marketed under the Phoenix brand. FDA UDI
Model / Reference
Phoenix FDA UDI
Description
Lightweight carbon fiber electric wheelchair with foldable frame, airline-approved lithium battery, and joystick controller. Marketed under the Phoenix brand. FDA UDI

Identifiers

Catalog Number
Phoenix FDA UDI
Primary DI / UDI-DI
00810203610018 FDA UDI
510(k) Number
K243440 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

ComfyGO by ComfyGO, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ComfyGO, Inc

Sources (1)

  • FDA UDI 7eaaf7e7-1c8a-4e34-9938-51955f3e1330 37 fields · synced May 30, 2026