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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN LIU JIA YI TECHNOLOGY CO.,LTD. RONDEX; MASSAGER, THERAPEUTIC, ELECTRIC

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SHENZHEN LIU JIA YI TECHNOLOGY CO.,LTD. RONDEX; MASSAGER, THERAPEUTIC, ELECTRIC Back to Search Results
Model Number B0CCRLRCXS
Patient Problems Pain (1994); Electric Shock (2554); Unspecified Heart Problem (4454)
Event Type  Other  
Event Description
I found that during use this product made me feel very painful.The current of ems is not something that humans can bear.I have a underlying heart condition, and the intensity of this current put me in the hospital.I learned that this type of product is listed on amazon.It needs to be audited by the fda.I would like to know whether the fda has actually audited the seller's information? based on our trust in the fda, i am sending this email for confirmation.I hope the fda can seriously review every seller.This is the protection of our consumers.In addition, it is unreasonable for this product to have so many reviews in a short period of time, which can prove that it deceives consumers through illegal behaviors.As a merchant who often deceives buyers, i have reason to suspect that he uses illegal channels to avoid fda review.
 
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Brand Name
RONDEX
Type of Device
MASSAGER, THERAPEUTIC, ELECTRIC
Manufacturer (Section D)
SHENZHEN LIU JIA YI TECHNOLOGY CO.,LTD.
MDR Report Key18311862
MDR Text Key330354214
Report NumberMW5149131
Device Sequence Number1
Product Code ISA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberB0CCRLRCXS
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/12/2023
Patient Sequence Number1
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