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DR-HO'S
Guangzhou Xinbo Electronic Co., Ltd. · Model XB-JT1000 · UDI-DI 06970742221497
10
510(k) clearances
42
Adverse events (1 deaths)
9
Recalls
115
Facilities
Description
Neck Comforter This product is used for the peripheral fixation of the neck and the longitudinal traction of the cervical vertebra.It is composed by cloth sleeves, three TPU round air bags and inflatable balls.It is mainly through stretching the cervical interspace under the inflatable state, reducing the pressure of the cervical interspace, improving the burden of the ligaments around the cervical vertebra, so that the injured cervical vertebra can get a full rest.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-14 | Smith & Nephew, Inc. | Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process |
| 2018-06-21 | Ossur Americas | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium |
| 2018-06-21 | Ossur Americas | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
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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.