Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kunshan Hi-Fortune Health Products Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
449 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244003 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-03-26 | 90 | 0 |
| K243961 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-02-12 | 51 | 0 |
| K243962 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-02-12 | 51 | 0 |
| K241337 | Electrically powered wheelchair (HP202) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2024-10-17 | 157 | 0 |
| K241632 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2024-10-16 | 132 | 0 |
| K212503 | HP458E Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2022-01-18 | 162 | 0 |
| K211647 | HP358EA Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2022-01-04 | 221 | 0 |
| K201855 | Electrically Powered Wheelchair -Model HP358E | Kunshan Hi-Fortune Health Products Co., Ltd. | 2021-09-28 | 449 | 0 |
| K163352 | Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2017-07-28 | 240 | 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