Kunshan Hi-Fortune Health Products Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Kunshan Hi-Fortune Health Products Co., Ltd.” (first 2017, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 157 days. Since 2017 the median was 157 days, against 122 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 |
|---|---|---|
| 2017 | 1 | 240 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 449 |
| 2022 | 2 | 192 |
| 2023 | 0 | — |
| 2024 | 2 | 144 |
| 2025 | 3 | 51 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kunshan Hi-Fortune Health Products Co., Ltd. took a median 157 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 8 | 8 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
Most recent Kunshan Hi-Fortune Health Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K244003 | Electrically powered wheelchair | ITI | 2025-03-26 | 90 |
| K243962 | Electrically Powered Wheelchair | ITI | 2025-02-12 | 51 |
| K243961 | Electrically Powered Wheelchair | ITI | 2025-02-12 | 51 |
| K241337 | Electrically powered wheelchair (HP202) | ITI | 2024-10-17 | 157 |
| K241632 | Electrically powered wheelchair | ITI | 2024-10-16 | 132 |
| K212503 | HP458E Electrically Powered Wheelchair | ITI | 2022-01-18 | 162 |
| K211647 | HP358EA Electrically Powered Wheelchair | ITI | 2022-01-04 | 221 |
| K201855 | Electrically Powered Wheelchair -Model HP358E | ITI | 2021-09-28 | 449 |
| K163352 | Wheelchair | IOR | 2017-07-28 | 240 |
Recalls
openFDA lists no recalls under a recalling firm named Kunshan Hi-Fortune Health Products 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.
- Kunshan Jiehong Nonwoven Product Co., Ltd. (2 510(k)s)
- Kunshan Aoshida Electric Technology Co., Ltd. (1 510(k)s)
- Kunshan Bella Optical Technology Co., Ltd. (1 510(k)s)
- Kunshan Deyi Plastic Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kunshan Hi-Fortune Health Products Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Kunshan Hi-Fortune Health Products Co., Ltd.” (first 2017, latest 2025), across 2 product codes 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 Kunshan Hi-Fortune Health Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kunshan Hi-Fortune Health Products Co., Ltd. is 157 days. Since 2017: 157 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kunshan Hi-Fortune Health Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 8); IOR (Wheelchair, Mechanical, 1).
Next steps
- See all 9 Kunshan Hi-Fortune Health Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Kunshan Hi-Fortune Health Products 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.