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Empluse

FDA UDI

Class I (US FDA UDI)

by Sunrise Medical (US) LLC

Identity

Trade Name
Empluse FDA UDI
Generic Name
Wheelchair electric-motor-driven propulsion system FDA UDI
Device Name
The R20 device is intended to be used by the assistant of a wheelchair user to aid in the propulsion of the chair and user over interior and exterior terrain. FDA UDI
Model / Reference
R20 FDA UDI
Description
The R20 device is intended to be used by the assistant of a wheelchair user to aid in the propulsion of the chair and user over interior and exterior terrain. FDA UDI

Identifiers

Catalog Number
EISP9 FDA UDI
Primary DI / UDI-DI
00016958059366 FDA UDI
FDA Product Code
KNO FDA UDI
GMDN Term
Wheelchair electric-motor-driven propulsion system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wheelchair electric-motor-driven propulsion system

Empluse by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair electric-motor-driven propulsion system.

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 a7be082f-4487-418f-a312-3858c57e931f 34 fields · synced Jun 9, 2026