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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REJUVACARE, LLC. REJUCAFLOW 3-IN-1 LEG MASSAGER; MASSAGER, THERAPEUTIC, ELECTRIC
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REJUVACARE, LLC. REJUCAFLOW 3-IN-1 LEG MASSAGER; MASSAGER, THERAPEUTIC, ELECTRIC Back to Search Results
Health Effect - Clinical Code Superficial (First Degree) Burn (2685)
Date of Event 12/23/2025
Type of Reportable Event Serious Injury
Event or Problem Description
I used the rejuvacareflow electric leg massager on both my legs on 2 separate days and suffered minor ski burns on the front of both calfs.This company manufactures and markets numerous devices for use in "relaxing" joints and extremities using carefully worded language that implies but does not actually use technical terms that step over the line of medical treatment, obviously with the intent to bypass the fda approval process.Based on my experience, these devices can be dangerous and actually injure users and i suggest the fda initiate and thorough investigation and seek to evaluate the safety of these devices.The company has reimbursed me for the device.
 
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Brand Name
REJUCAFLOW 3-IN-1 LEG MASSAGER
Common Device Name
MASSAGER, THERAPEUTIC, ELECTRIC
Manufacturer (Section D)
REJUVACARE, LLC.
MDR Report Key23974173
Report NumberMW5181783
Device Sequence Number12942027
Product Code ISA
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 12/27/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/06/2026
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
AMLODIPINE; ATORVASTATIN; HYDROCHLOROTHIAZIDE ; LOW-DOSE ASPIRIN; SYNTHROID
Patient Age76 YR
Patient SexFemale
Patient Weight91 KG
Patient EthnicityHispanic
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