FDA applicant
Sofwave Medical, Ltd.
FDA records 12 decisions for Sofwave Medical, Ltd. (Yokneam Iiit, IL) from 2019 to 2025: 12 510(k) clearances. Most are in product codes OHV (Focused Ultrasound For Tissue Heat Or…) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 10 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 Sofwave Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Sofwave Medical, 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