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The Tracker / October 2026 / K261574

510(k) cleared

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)

Hong Qiangxing (Shenzhen) Electronics Limited · Oct 16, 2026 · K261574

FDA cleared the Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) from Hong Qiangxing (Shenzhen) Electronics Limited on Oct 16, 2026 under K261574, a traditional 510(k). The device falls under product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 12, 2026. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hong Qiangxing (Shenzhen) Electronics Limited has one other decision in the tracker over the last 12 months: K253740 (TENS&EMS (HZ9151B, HZ9151C, HZ9151D)).

Questions & Answers

What did FDA clear under K261574?

K261574 is the FDA 510(k) for Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143), submitted by Hong Qiangxing (Shenzhen) Electronics Limited. FDA's decision date was Oct 16, 2026, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)?

Hong Qiangxing (Shenzhen) Electronics Limited, based in Shenzhen, is the applicant of record for K261574.

How long did the K261574 review take?

FDA received the submission on May 12, 2026 and issued its decision on Oct 16, 2026, 157 days later.

← All decisions in October 2026

Sources