Monotrode 101
Model 101 · MYOTRONICS NOROMED, INC · DI D7921013
KZM — Device, Muscle Monitoring · Class II · 21 CFR 890.1375
NUW — Stimulator, Muscle, Powered, Dental · Class II · 21 CFR 890.5850
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