Belifu TENS (UDI 00321911080500)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00321911080500), received between Feb 10, 2020 and Dec 15, 2020 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem

  USED IT FOR 10 MINUTES ON MY LOWER BACK ONLY FOR THE PADS TO BECOME SUPER ITCHY. LEFT RED INFLAMED PATCHES THE EXACT SIZE OF THE PADS FOR 2 WEEKS. SINCE THE SWELLING HAS WENT DOWN THERE ARE DARK ALMOST "TANNED" PATCHES THAT SEEM LIKE THEY WILL NEVER GO AWAY. IT'S BEEN OVER 2 MONTHS. BOUGHT ON (B)(6), THE LINK WAS (B)(6). FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Itching Sensation; Skin Discoloration; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 11019252 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem

  IT IS A TENS PRODUCT. BOUGHT ON (B)(6) FOR TRAPS AND NECK PAIN. USED ONCE ON A FRIDAY AND WOKE UP SATURDAY WITH SKIN PETECHIA/ELECTRICAL BURNS ON LEFT HAND AND FOREARM. THE PRODUCT LINK IS (B)(6). FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Burn, Thermal; Skin Inflammation

  MAUDE report 10991679 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem

  SKIN BURNED BY THE TENS ELECTRODES!!!! I. WE ARE REPORTING UNLAWFUL SALES OF MEDICAL PRODUCTS ON THE INTERNET; THE REPORTED DEVICE BEING SOLD ON (B)(6) DOES NOT MEET THE SPECIFICATIONS IN THE 510 (K) PREMARKET SUBMISSION; THE REPORTED DEVICE IS BEING SOLD ON (B)(6) BEFORE THE 510 (K) CLEARANCE IS GRANTED. THE REPORTED (B)(6) SELLER SHENZHEN HUAYAN E-COMMERCE CO., LTD DOES NOT REGISTER THEIR ESTABLISHMENT ON FDA. II. INFORMATION ABOUT THE SELLER, PRODUCT, MANUFACTURER WHICH ARE BEING REPORTED; PRODUCT AND SELLER¿S INFORMATION ON (B)(6). PRODUCT PAGE LINK FROM (B)(6). SELLER NAME ON (B)(6), BRAND NAME: BELIFU. SELLER¿S COMPANY NAME: SHENZHEN HUAYAN E-COMMERCE CO., LTD. ONE PRIMARY ID NUMBER FROM PHOTOS OF PRODUCT REVIEWS? (B)(4)? PLEASE REFER TO THE LINK OF REVIEW: (B)(6); MANUFACTURER¿S INFORMATION FROM FDA? HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFRL/RL.CFM?START_SEARCH=1&SHOWLIST+1&ESTABLISHMENTNAME=®NUM=&STATENAME=&COUNTRYNAME=®ISTRATIONNUMBER=3010402752&OWNEROPERATORNUMBER=&OWNEROPERATORNAME=&PRODUCTCODE=&DEVICENAME=&PROPIETARYNAME=&ESTABLISHMENTTYPE=&PAGENUM=10&SORTCOLUMN=ESTABLISHMENTNAME20%25ASC. DEVICE FOREIGN MANUFACTURER: HONG QIANGXING (SHEN ZHEN) ELECTRONICS

  Patient problems: Burn, Thermal

  MAUDE report 9694283 ↗