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Jwx-2

FDA UDI

Class II (US FDA UDI)

by Sunrise Medical (US) LLC

Identity

Trade Name
JWX-2 FDA UDI
Generic Name
Wheelchair, power-assisted, occupant-controlled, non-collapsible FDA UDI
Device Name
Electric Power assist Unit for Wheelchairs FDA UDI
Model / Reference
XT FDA UDI
Description
Electric Power assist Unit for Wheelchairs FDA UDI

Identifiers

Catalog Number
XT FDA UDI
Primary DI / UDI-DI
05022408056767 FDA UDI
510(k) Number
K140204 FDA UDI
FDA Product Code
ITI FDA UDI
GMDN Term
Wheelchair, power-assisted, occupant-controlled, non-collapsible FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3860 FDA UDI
Commercial Distribution
Not 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

Jwx-2 by Sunrise Medical (US) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K140204 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sunrise Medical (US) LLC

Sources (1)

  • FDA UDI 086aad39-d6ba-47ce-89dc-4f64b35b3ed6 37 fields · synced Jun 9, 2026