Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Yicai Health Technology Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K106 | Shenzhen Yicai Health Technology Co., Ltd. | 2025-09-17 | 112 | 0 |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K | Shenzhen Yicai Health Technology Co., Ltd. | 2025-08-21 | 160 | 0 |
| K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) | Shenzhen Yicai Health Technology Co., Ltd. | 2024-07-22 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda