Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Shenzhen Carewell Electronics Co., Ltd. with 3 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Mar 20, 2020: AI-ECG Tracker.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 20, 2020 | AI-ECG TrackerK200036 · DPS | 510(k) clearances |
| Mar 20, 2020 | AI-ECG TrackerK200036 · Cardiovascular | AI-enabled devices |
| Nov 19, 2018 | AI-ECG PlatformK180432 · DQK | 510(k) clearances |
| Nov 19, 2018 | AI-ECG PlatformK180432 · Cardiovascular | AI-enabled devices |
| Apr 25, 2012 | ELECTROCARDIOGRAPHK113485 · DPS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
