Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hong Qiangxing (Shenzhen) Electronics Limited — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
333 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | 2025-12-23 | 29 | 0 |
| K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, S | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-05-02 | 90 | 0 |
| K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-04-19 | 90 | 0 |
| K220150 | TENS & PMS (Model: SM9126) | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-02-17 | 29 | 0 |
| K201354 | TENS & PMS | Hong Qiangxing (Shenzhen) Electronics Limited | 2020-12-11 | 204 | 0 |
| K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | Hong Qiangxing (Shenzhen) Electronics Limited | 2019-12-02 | 333 | 0 |
| K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | 2019-03-26 | 132 | 0 |
| K133108 | FIT BELT | Hong Qiangxing (Shenzhen) Electronics Limited | 2014-08-05 | 309 | 0 |
| K121719 | SM TENS & PMS | Hong Qiangxing (Shenzhen) Electronics Limited | 2013-05-10 | 333 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda