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DR-HO'S

Guangzhou Xinbo Electronic Co., Ltd. · Model Size A/B · UDI-DI 06970742221466

HST
10
510(k) clearances
519
Adverse events (3 deaths)
11
Recalls
202
Facilities

Description

Decompression Belt This product is used for external fixation of the waist and longitudinal traction of the lumbar spine.It is composed by traction belt and air pump

Recalls

DateFirmReason
2024-03-11Baxter Healthcare CorporationBaxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking
2017-01-03Allen Medical Systems, Inc.During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery
2016-11-23Allen Medical Systems, Inc.During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to th
2014-12-29Dick's Sporting GoodsReports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a fitness product, not a medical device. DSG removed medical claims from produ
2014-01-29Implantech Associates IncImplantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro
2013-05-20Steris CorporationA bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was
2013-02-28Allen Medical Systems, Inc.Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.
2013-02-14Zimmer, Inc.The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
2009-07-31Linvatec Corp. dba ConMed LinvatecConMed has determined there is a possibility that the device may not fully retract once it is deployed.
2009-07-27Stryker EndoscopyLatex-- Certain lots of Product contain undeclared latex.

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Data 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.