FDA applicant
Hong Qiangxing (Shenzhen) Electronics Limited
FDA records 10 decisions for Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN) from 2013 to 2026: 10 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hong Qiangxing (Shenzhen) Electronics Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Hong Qiangxing (Shenzhen) Electronics…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Hong”
FDA records each applicant name separately; these may or may not be the same firm.