Empluse EISP9

GUDID 00016958059366

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.

SUNRISE MEDICAL (US) LLC

Wheelchair electric-motor-driven propulsion system
Primary Device ID00016958059366
NIH Device Record Keya7be082f-4487-418f-a312-3858c57e931f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpluse
Version Model NumberR20
Catalog NumberEISP9
Company DUNS962525056
Company NameSUNRISE MEDICAL (US) LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100016958059366 [Primary]

FDA Product Code

KNOAccessories, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-01
Device Publish Date2024-07-24

Devices Manufactured by SUNRISE MEDICAL (US) LLC

00016958059366 - Empluse2024-08-01The 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.
00016958059366 - Empluse2024-08-01 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
00016958059465 - Empulse 2024-07-04 The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual prop
00016958045918 - Zippie GS2024-02-02 The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations, and folding and rigid frame whe
00016958057034 - Zippie X'Cape2024-02-02 The ZIPPIE X’CAPE® pediatric folding wheelchair is the first ever wheelchair with XLOCK® technology for the performance of a
00016958057041 - Quickie 5R2024-02-02 The Quickie® 5R is designed to deliver superior rigid wheelchair performance day after day. As you and your environment evolve,
00016958047349 - Zippie TS SE2023-11-22 The Zippie® TS is the original, premier pediatric tilt-in-space wheelchair. Available with either a folding or rigid frame, bui
00016958060850 - Switch-it 2023-11-22 The Ctrl+5 box allows you to easily access power seating controls right at your fingertips. Designed with five buttons or toggle
00016958047325 - Jay 2023-11-20 JAY® Fit Seating simplifies the world of made-to-order seating by offering a "semi-personalized" solution. A great option for i

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