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 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Truly Instrument Co., Ltd. with 10 510(k) clearances. The most recent is a 510(k) clearance dated Feb 17, 2023: Infrared Thermometer TET-351.
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.
| Feb 17, 2023 | Infrared Thermometer TET-351K220276 · FLL | 510(k) clearances |
| Dec 23, 2019 | Arm Blood Pressure MonitorK192023 · DXN | 510(k) clearances |
| Nov 21, 2017 | Automatic Wrist Bluetooth Blood Pressure MonitorK170545 · DXN | 510(k) clearances |
| Oct 24, 2016 | Automatic Arm Bluetooth Blood Pressure MonitorK161846 · DXN | 510(k) clearances |
| Jan 19, 2012 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORK113083 · DXN | 510(k) clearances |
| Jan 12, 2012 | TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITORK113085 · DXN | 510(k) clearances |
| Sep 4, 2009 | TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702MK091415 · DXN | 510(k) clearances |
| Sep 4, 2009 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63MK091434 · DXN | 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
