Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list JKH USA, LLC with 9 510(k) clearances. The most recent is a 510(k) clearance dated Aug 31, 2021: PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS….
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.
| Aug 31, 2021 | PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AGK203636 · FLL | 510(k) clearances |
| Feb 5, 2021 | Patient Monitoring CablesK203635 · DSA | 510(k) clearances |
| Jan 6, 2021 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740DK203652 · DXQ | 510(k) clearances |
| Nov 27, 2020 | Spo2 SensorK202851 · DQA | 510(k) clearances |
| Sep 15, 2020 | Massage Compression BootsK201645 · IRP | 510(k) clearances |
| Sep 8, 2020 | Disposable Medical Face MaskK201470 · FXX | 510(k) clearances |
| Sep 21, 2019 | Medi-Direct TENS PenK182671 · NUH | 510(k) clearances |
| Jun 21, 2019 | JKH Stimulator PlusK191151 · NUH | 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
