FDA applicant
Weero Co., Ltd.
FDA records 6 decisions for Weero Co., Ltd. (Suwon, KR) from 2022 to 2026: 6 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 194 days from receipt to decision, against 216 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Weero Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Weero Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Weero Co., 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