Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Thought Technology , Ltd. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
559 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213197 | MyOnyx System | Thought Technology , Ltd. | 2022-06-17 | 261 | 0 |
| K201014 | MyOnyx System | Thought Technology , Ltd. | 2021-01-13 | 271 | 0 |
| K053434 | MYOTRAC INFINITI ELECTRICAL STIMULATOR | Thought Technology , Ltd. | 2006-03-15 | 96 | 0 |
| K053266 | MYOTRAC INFINITI | Thought Technology , Ltd. | 2005-12-29 | 36 | 0 |
| K925681 | MYOTRAC2D/CS | Thought Technology , Ltd. | 1995-09-29 | 1081 | 0 |
| K935213 | INCONTROL | Thought Technology , Ltd. | 1995-05-11 | 559 | 0 |
| K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE | Thought Technology , Ltd. | 1995-05-11 | 737 | 0 |
| K915859 | MYOTRAC/S, MYODAC/S | Thought Technology , Ltd. | 1992-09-09 | 257 | 0 |
| K915858 | MYOTRAC2 | Thought Technology , Ltd. | 1992-09-09 | 257 | 0 |
| K913898 | MYOTRAC+/S, MYODAC+/S | Thought Technology , Ltd. | 1992-03-26 | 209 | 0 |
| K903497 | FLEXCOMP DSP & PROCOMP | Thought Technology , Ltd. | 1991-02-12 | 193 | 0 |
| K896409 | M(3):MICRO MUSCLE MONITOR | Thought Technology , Ltd. | 1990-10-09 | 336 | 0 |
| K894840 | MYODAC2 BIOFEEDBACK DEVICE | Thought Technology , Ltd. | 1989-10-13 | 85 | 0 |
| K883597 | MYODAC | Thought Technology , Ltd. | 1988-11-16 | 86 | 0 |
| K881416 | MYOTRAC | Thought Technology , Ltd. | 1988-09-26 | 175 | 0 |
| K850642 | TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA | Thought Technology , Ltd. | 1985-05-17 | 87 | 0 |
| K850643 | HR/BVP 100T HEART RATE MONITOR | Thought Technology , Ltd. | 1985-05-17 | 87 | 0 |
| K834519 | CALMTONE | Thought Technology , Ltd. | 1984-01-30 | 40 | 0 |
| K831955 | HR 100T | Thought Technology , Ltd. | 1983-08-11 | 55 | 0 |
| K823146 | CALMSET 3 TM | Thought Technology , Ltd. | 1982-12-03 | 39 | 0 |
| K822814 | EMG 100T | Thought Technology , Ltd. | 1982-10-08 | 18 | 0 |
| K810332 | SC/TEMP 300 | Thought Technology , Ltd. | 1981-05-18 | 98 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda