510(k) K261574
K261574 is an FDA 510(k) premarket notification submitted by Hong Qiangxing (Shenzhen) Electronics Limited for the device "Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Hong Qiangxing (Shenzhen) Electronics Limited has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2026
- Date Received
- May 12, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES