Belifu TENS (UDI 00321908130010)Recalls & reported problems
Hong Qiangxing (Shen Zhen) Electronics Limited · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00321908130010), received between Dec 8, 2020 and Dec 8, 2020 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)1
- Erythema1
- Hypersensitivity/Allergic reaction1
- Itching Sensation1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem
I GOT A SHARP PAIN WHEN I AM USING THE TENS UNIT AND SAW THE PADS LEFT MILD BURNS ON MY SKIN. IT IS LIKE ALLERGY SYMPTOMS AND THE SKIN WAS ITCHING AND REDNESS FOR SEVERAL DAYS AND RECOVERED IF I STOPPED USING IT. BUT IF I RESTART USING IT, IT LEFT BURNS ON THE SKINS AGAIN. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Burn(s); Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Pain
MAUDE report 10976020 ↗
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- Richmar TheraTouch DQ7200Drive Devilbiss Healthcare · Stimulator, Nerve, Transcutaneous, For Pain Relief4 reports
- Belifu TENSHong Qiangxing (Shen Zhen) Electronics Limited · Stimulator, Nerve, Transcutaneous, For Pain Relief3 reports
- Richmar TheraTouch DQ8200Drive Devilbiss Healthcare · Stimulator, Nerve, Transcutaneous, For Pain Relief2 reports
- BioStim SDBiomedical Life Systems, Inc. · Stimulator, Nerve, Transcutaneous, For Pain Relief1 report
- CHATTANOOGA 7560Djo, LLC · STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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