FDA applicant
Bozhou Rongjian Medical Appliance Co., Ltd.
FDA records 5 decisions for Bozhou Rongjian Medical Appliance Co., Ltd. (Bozhou, CN) from 2022 to 2026: 5 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and NUH (Stimulator, Nerve, Transcutaneous…). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Bozhou Rongjian Medical Appliance Co., Ltd.’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 2022.
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