Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Intradin (Shanghai) Machinery Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-11-21 | 98 | 0 |
| K243970 | Portable Wheelchair | Intradin (Shanghai) Machinery Co., Ltd. | 2025-03-07 | 74 | 0 |
| K250027 | Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd. | 2025-02-21 | 46 | 0 |
| K232692 | Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GU | Intradin (Shanghai) Machinery Co., Ltd. | 2024-09-05 | 366 | 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