Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hong Qiangxing (Shenzhen) Electronics Limited and its 1 subsidiaries with 10 510(k) clearances and 1 warning letter. The most recent is a 510(k) clearance dated Oct 16, 2026: Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Hong Qiangxing (Shenzhen) Electronics Limited and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 16, 2026 | Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)K261574 · NUH | 510(k) clearances |
| Dec 23, 2025 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K253740 · NUH | 510(k) clearances |
| Oct 28, 2025 | Warning letter: CAPA, Complaint handling, MDR reportingCDRH | Warning letters |
| May 2, 2022 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220283 · NUH | 510(k) clearances |
| Apr 19, 2022 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220152 · NUH | 510(k) clearances |
| Feb 17, 2022 | TENS & PMS (Model: SM9126)K220150 · NUH | 510(k) clearances |
| Dec 11, 2020 | TENS & PMSK201354 · NGX | 510(k) clearances |
| Dec 2, 2019 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K190009 · NUH | 510(k) clearances |
| Mar 26, 2019 | SM ElectrodesK183154 · GXY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
