FDA applicant
Shenzhen Dongdixin Technology Co., Ltd.
FDA records 27 decisions for Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN) from 2005 to 2026: 27 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and IPF (Stimulator, Muscle, Powered). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Dongdixin Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Shenzhen Dongdixin Technology Co., Ltd.’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) Report