FDA applicant
Shenzhen Roundwhale Technology Co., Ltd.
FDA records 7 decisions for Shenzhen Roundwhale Technology Co., Ltd. (Shenzhen, CN) from 2018 to 2024: 7 510(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 111 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 1 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 Shenzhen Roundwhale Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Shenzhen Roundwhale 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.
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