FDA applicant
Actegy, Ltd.
FDA records 7 decisions for Actegy, Ltd. (Bracknell, GB) from 2013 to 2021: 7 510(k) clearances. Most are in product codes NGX (Stimulator, Muscle, Powered, For Muscle…) and BWF (Spirometer, Therapeutic (Incentive)). Since 2016 its 510(k)s took a median of 210 days from receipt to decision, against 224 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Actegy, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Actegy, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report