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Thought Technology , Ltd.

FDA Regulatory Profile

Thought Technology , Ltd. has 0 FDA recalls, 2 inspections, 22 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 25, 2012 · NAI
Latest 510(k)
Jun 17, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances22Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 25, 2012Montreal-Ouest, CanadaDevicesNo Action Indicated (NAI)1000639819
Oct 21, 2010Montreal-Ouest, CanadaDevicesNo Action Indicated (NAI)1000639819

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K213197MyOnyx SystemJun 17, 2022
K201014MyOnyx SystemJan 13, 2021
K053434MYOTRAC INFINITI ELECTRICAL STIMULATORMar 15, 2006
K053266MYOTRAC INFINITIDec 29, 2005
K925681MYOTRAC2D/CSSep 29, 1995
K935213INCONTROLMay 11, 1995
K932149THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODEMay 11, 1995
K915858MYOTRAC2Sep 9, 1992
K915859MYOTRAC/S, MYODAC/SSep 9, 1992
K913898MYOTRAC+/S, MYODAC+/SMar 26, 1992
K903497FLEXCOMP DSP & PROCOMPFeb 12, 1991
K896409M(3):MICRO MUSCLE MONITOROct 9, 1990
K894840MYODAC2 BIOFEEDBACK DEVICEOct 13, 1989
K883597MYODACNov 16, 1988
K881416MYOTRACSep 26, 1988
K850643HR/BVP 100T HEART RATE MONITORMay 17, 1985
K850642TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBAMay 17, 1985
K834519CALMTONEJan 30, 1984
K831955HR 100TAug 11, 1983
K823146CALMSET 3 TMDec 3, 1982

FDA data resources