Thought Technology , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 22
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213197 | MyOnyx System | June 17, 2022 |
| K201014 | MyOnyx System | January 13, 2021 |
| K053434 | MYOTRAC INFINITI ELECTRICAL STIMULATOR | March 15, 2006 |
| K053266 | MYOTRAC INFINITI | December 29, 2005 |
| K925681 | MYOTRAC2D/CS | September 29, 1995 |
| K935213 | INCONTROL | May 11, 1995 |
| K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE | May 11, 1995 |
| K915858 | MYOTRAC2 | September 9, 1992 |
| K915859 | MYOTRAC/S, MYODAC/S | September 9, 1992 |
| K913898 | MYOTRAC+/S, MYODAC+/S | March 26, 1992 |
| K903497 | FLEXCOMP DSP & PROCOMP | February 12, 1991 |
| K896409 | M(3):MICRO MUSCLE MONITOR | October 9, 1990 |
| K894840 | MYODAC2 BIOFEEDBACK DEVICE | October 13, 1989 |
| K883597 | MYODAC | November 16, 1988 |
| K881416 | MYOTRAC | September 26, 1988 |
| K850642 | TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA | May 17, 1985 |
| K850643 | HR/BVP 100T HEART RATE MONITOR | May 17, 1985 |
| K834519 | CALMTONE | January 30, 1984 |
| K831955 | HR 100T | August 11, 1983 |
| K823146 | CALMSET 3 TM | December 3, 1982 |