Xiamen Weiyou Intelligent Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Xiamen Weiyou Intelligent Technology Co., Ltd.” (first 2021, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 184 days. Since 2017 the median was 184 days, against 128 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 |
|---|---|---|
| 2021 | 2 | 192 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 143 |
| 2025 | 1 | 34 |
| 2026 | 2 | 202 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xiamen Weiyou Intelligent Technology Co., Ltd. took a median 184 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | 7 | 7 |
Review panels
Most recent Xiamen Weiyou Intelligent Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253919 | Cryo And Thermo Therapy System | IRP | 2026-06-10 | 184 |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | IRP | 2026-04-30 | 220 |
| K243791 | Air Pressure Therapy System | IRP | 2025-01-13 | 34 |
| K243320 | Air Pressure Therapy System (VU-IPC04B) | IRP | 2024-11-18 | 26 |
| K233238 | Air Pressure Therapy System (Model:VU-IPC4M) | IRP | 2024-06-14 | 260 |
| K201935 | Air Pressure Therapy System | IRP | 2021-06-22 | 344 |
| K210967 | Air Pressure Therapy System: VU-IPC06 | IRP | 2021-05-11 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Xiamen Weiyou Intelligent Technology Co., 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Xiamen Probtain Medical Techology Co., Ltd. (4 510(k)s)
- Xiamen Ants Bro Technology Co., Ltd. (3 510(k)s)
- Xiamen Senyang Co., Ltd. (3 510(k)s)
- Xiamen Acurio Instruments Co., Ltd. (2 510(k)s)
- Xiamen Compower Medical Tech. Co., Ltd. (2 510(k)s)
- Xiamen Double Engine Medical Material Co., Ltd. (2 510(k)s)
- Xiamen High Top Electronic Technology Co., Ltd. (2 510(k)s)
- Xiamen Blue Star Enterprise Co., Ltd. (1 510(k)s)
- Xiamen Chenyi Plastics Industrial Co. , Ltd. (1 510(k)s)
- Xiamen Chingsong Optical Industrial Co., Ltd. (1 510(k)s)
- Xiamen Comfier Technology Co., Ltd. (1 510(k)s)
- Xiamen Double Engline Medical Material Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xiamen Weiyou Intelligent Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Xiamen Weiyou Intelligent Technology Co., Ltd.” (first 2021, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xiamen Weiyou Intelligent Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xiamen Weiyou Intelligent Technology Co., Ltd. is 184 days. Since 2017: 184 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Xiamen Weiyou Intelligent Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are IRP (Massager, Powered Inflatable Tube, 7).
Next steps
- See all 7 Xiamen Weiyou Intelligent Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IRP, Xiamen Weiyou Intelligent Technology Co., 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.