Actegy , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Actegy , Ltd.” (first 2013, latest 2021), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 213 days. Since 2017 the median was 207 days, against 153 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 240 |
| 2014 | 1 | 267 |
| 2015 | 1 | 136 |
| 2016 | 1 | 213 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 87 |
| 2020 | 1 | 207 |
| 2021 | 1 | 273 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Actegy , Ltd. took a median 207 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 153 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 5 | 5 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Physical Medicine (6)
- Anesthesiology (1)
Most recent Actegy , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210825 | Revitive Medic Coach (Model Number 5575AQ) | NGX | 2021-12-17 | 273 |
| K192887 | Revitive Medic Plus, Revitive Advanced 2 | NGX | 2020-05-04 | 207 |
| K190924 | Revitive Medic Plus, Revitive Advanced 2 | NGX | 2019-07-05 | 87 |
| K152480 | Revitive Medic; Revitive MV; Revitive LV | NGX | 2016-03-31 | 213 |
| K143207 | Revitive IX (OTC) | NGX | 2015-03-23 | 136 |
| K140772 | AEROSURE MEDIC | BWF | 2014-12-19 | 267 |
| K123354 | REVITIVE IX | IPF | 2013-06-28 | 240 |
Recalls
openFDA lists no recalls under a recalling firm named Actegy , 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.
Device clinical trials
An industry sponsor named Actegy , Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02007590: Aerosure and Six Minute Walk Distance in Severe COPD (Completed, started 2014-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Actegy , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Actegy , Ltd.” (first 2013, latest 2021), across 3 product codes in 2 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 Actegy , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Actegy , Ltd. is 213 days. Since 2017: 207 days, versus 153 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Actegy , Ltd.?
The most frequent FDA product codes under this applicant name are NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 5); BWF (Spirometer, Therapeutic (Incentive), 1); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 7 Actegy , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NGX, Actegy , 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.