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Empluse
SUNRISE MEDICAL (US) LLC · Model R20 · UDI-DI 00016958059366
10
510(k) clearances
67
Adverse events (4 deaths)
3
Recalls
220
Facilities
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-02 | Merits Holdings Co. dba Merits Health Products, Inc. | Pinion gear may disengage from track allowing lift to slip or jolt. |
| 2004-02-02 | Action Products Incorporated | Wheelchair seat may not properly support the user due to cracks in the plastic seat base. |
| 2002-05-14 | Action Products Incorporated | Wheelchair seat component is defective. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.