REJUCAFLOW 3-IN-1 LEG MASSAGER
Received Jan 6, 2026 · Event occurred Dec 23, 2025
Report MW5181783 · MDR key 23974173
Device
Generic name
Massager, Therapeutic, Electric
Manufacturer
Rejuvacare, Llc.Patient
76 YR · Female
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
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.