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K7 CMS Sensor Array

Model K7 CMS Sensor Array · MYOTRONICS NOROMED, INC · DI D79209960

NFS — Device, Jaw Tracking, For Monitoring Jaw Positions · Class I · 21 CFR 872.2060

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — MYOTRONICS NOROMED, INC

  • Warning Letter 2012-04-09 Myotronics-Noromed Inc
  • Warning Letter 2012-04-09 Myotronics-Noromed Inc
  • NAI 2017-03-15 Myotronics-Noromed Inc · 0 citations
  • NAI 2017-03-15 Myotronics-Noromed Inc · 0 citations
  • NAI 2013-11-20 Myotronics-Noromed Inc · 0 citations
  • NAI 2013-11-20 Myotronics-Noromed Inc · 0 citations
  • NAI 2012-07-24 Myotronics-Noromed Inc · 0 citations
  • NAI 2012-07-24 Myotronics-Noromed Inc · 0 citations
  • OAI 2011-05-12 Myotronics-Noromed Inc · 2 citations
  • OAI 2011-05-12 Myotronics-Noromed Inc · 2 citations