510(k) clearance
Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
- 510(k) number
- K261574
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited
- Decision date
- Oct 16, 2026
- Date received
- May 12, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NUH
- Device type
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device class
- Class II
- Regulation
- 21 CFR 882.5890
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN