Teleemg, LLC: FDA clearances and approvals
Teleemg, LLC has 5 FDA 510(k) clearances (first 2016, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 192 days. Since 2017 its median was 114 days, against 141 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 322 |
| 2017 | 1 | 37 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 178 |
| 2024 | 0 | — |
| 2025 | 1 | 192 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Teleemg, LLC's cleared 510(k)s took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 141 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | 3 | 3 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | 2 | 2 |
Review panels
- Neurology (5)
Most recent Teleemg, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250689 | CloudTMS Edge | OBP | 2025-09-14 | 192 |
| K233742 | CloudTMS Edge for OCD | QCI | 2023-12-22 | 30 |
| K221129 | CloudTMS for OCD | QCI | 2023-03-10 | 326 |
| K173441 | Neurosoft TMS (also CloudTMS) | OBP | 2017-12-13 | 37 |
| K160309 | Neurosoft TMS | OBP | 2016-12-22 | 322 |
Recalls
openFDA lists no recalls under a recalling firm named Teleemg, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Teleemg, LLC have?
Teleemg, LLC has 5 FDA 510(k) clearances (first 2016, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Teleemg, LLC's 510(k)s?
The median time from FDA receipt to decision across Teleemg, LLC's cleared 510(k)s is 192 days. Since 2017: 114 days, versus 141 days for all cleared 510(k)s in the same product codes.
What devices does Teleemg, LLC make?
Its most frequent FDA product codes are OBP (Transcranial Magnetic Stimulator, 3); QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, 2).
Has Teleemg, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Teleemg, LLC. Related entities may recall under other names.
Next steps
- See all 5 Teleemg, LLC clearances with predicates and recalls
- Run predicate analysis for product code OBP, Teleemg, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.