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203-5 SHOWER CHAIR
ORMESA SRL · Model 203-5 SHOWER CHAIR · UDI-DI 08055715702833
10
510(k) clearances
3,241
Adverse events (13 deaths)
25
Recalls
189
Facilities
Description
Push wheelchair intended for the personal hygiene operations of users with disabilities, , semi-self-sufficient or non-self-sufficient users with poor head and trunk control, tending to lose contact with the surface of the backrest and slide with the pelvis forward and who assistance assistance in the care and hygiene of their own person to maintain stability and safety for the user and the assistant.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-11-19 | Ki Mobility Llc | The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. |
| 2021-07-08 | Sunrise Medical (US) LLC | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. |
| 2021-07-08 | Sunrise Medical (US) LLC | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. |
| 2021-06-21 | Accora Inc | The firm has identified a potential for the backrest to become detached from the chair. |
| 2019-03-28 | R82 A/S | Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat. |
| 2017-06-30 | R82 A/S | Replacement campaign on all units that have a gas spring head in aluminum. |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
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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.