Weero Co., Ltd.: FDA clearances and approvals
Weero Co., Ltd. has 6 FDA 510(k) clearances (first 2022, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 194 days. Since 2017 its median was 194 days, against 153 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 402 |
| 2023 | 0 | — |
| 2024 | 2 | 182 |
| 2025 | 1 | 379 |
| 2026 | 2 | 186 |
Review time against the same product codes
Since 2017, Weero Co., Ltd.'s cleared 510(k)s took a median 194 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 3 | 3 |
Review panels
Most recent Weero Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | IPF | 2026-06-08 | 206 |
| K253261 | Apollo Quattro (APQ-10M) | PBX | 2026-03-13 | 165 |
| K241433 | EVE Synergy (EVE-20M) | IPF | 2025-06-04 | 379 |
| K240992 | eMVFit (MVF-10M) | IPF | 2024-10-10 | 182 |
| K240991 | eMVFit (MVF-10M) | PBX | 2024-10-09 | 181 |
| K212253 | Apollo Duet (Model : APD-4000) | PBX | 2022-08-25 | 402 |
Recalls
openFDA lists no recalls under a recalling firm named Weero Co., Ltd..
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 Weero Co., Ltd. have?
Weero Co., Ltd. has 6 FDA 510(k) clearances (first 2022, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear Weero Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Weero Co., Ltd.'s cleared 510(k)s is 194 days. Since 2017: 194 days, versus 153 days for all cleared 510(k)s in the same product codes.
What devices does Weero Co., Ltd. make?
Its most frequent FDA product codes are IPF (Stimulator, Muscle, Powered, 3); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 3).
Has Weero Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Weero Co., Ltd. Related entities may recall under other names.
Next steps
- See all 6 Weero Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Weero Co., Ltd.'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.