Thought Technology , Ltd.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Thought Technology , Ltd.” (first 1981, latest 2022), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 136 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 271 |
| 2022 | 1 | 261 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Thought Technology , Ltd. took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HCC | Device, Biofeedback | 14 | 14 |
| HIR | Perineometer | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 | 1 |
Review panels
- Neurology (14)
- Gastroenterology and Urology (5)
- Physical Medicine (2)
- Cardiovascular (1)
Most recent Thought Technology , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213197 | MyOnyx System | IPF | 2022-06-17 | 261 |
| K201014 | MyOnyx System | KPI | 2021-01-13 | 271 |
| K053434 | MYOTRAC INFINITI ELECTRICAL STIMULATOR | KPI | 2006-03-15 | 96 |
| K053266 | MYOTRAC INFINITI | IPF | 2005-12-29 | 36 |
| K925681 | MYOTRAC2D/CS | HIR | 1995-09-29 | 1081 |
| K935213 | INCONTROL | HIR | 1995-05-11 | 559 |
| K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE | HIR | 1995-05-11 | 737 |
| K915859 | MYOTRAC/S, MYODAC/S | HCC | 1992-09-09 | 257 |
| K915858 | MYOTRAC2 | HCC | 1992-09-09 | 257 |
| K913898 | MYOTRAC+/S, MYODAC+/S | HCC | 1992-03-26 | 209 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Thought Technology , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Thought Technology , Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances are listed under Thought Technology , Ltd.?
FDA lists 22 510(k) clearances under the applicant name “Thought Technology , Ltd.” (first 1981, latest 2022), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thought Technology , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thought Technology , Ltd. is 136 days.
Which FDA product codes appear under Thought Technology , Ltd.?
The most frequent FDA product codes under this applicant name are HCC (Device, Biofeedback, 14); HIR (Perineometer, 3); IPF (Stimulator, Muscle, Powered, 2).
Next steps
- See all 22 Thought Technology , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HCC, Thought Technology , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.