FDA applicant
Shenzhen Carewell Electronics Co., Ltd.
FDA records 3 decisions for Shenzhen Carewell Electronics Co., Ltd. (Shenzhen, CN) from 2012 to 2020: 3 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DQK (Computer, Diagnostic, Programmable). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Shenzhen Carewell Electronics., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Carewell Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Shenzhen Carewell Electronics 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