Heartway Medical Products Co., Ltd.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Heartway Medical Products Co., Ltd.” (first 1997, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 46 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 328 |
| 2015 | 5 | 161 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 258 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Heartway Medical Products Co., Ltd. took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 15 | 15 |
| ITI | Wheelchair, Powered | 7 | 7 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
- Physical Medicine (23)
Most recent Heartway Medical Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220227 | Auto Folding Scooter, S21F | INI | 2022-10-12 | 258 |
| K151656 | HEARTWAY Power Mobility Scooter | INI | 2015-11-25 | 159 |
| K150998 | HEARTWAY Power Mobility Scooter | INI | 2015-09-29 | 167 |
| K150987 | HEARTWAY Power Mobility Scooter, BRIO S19 | INI | 2015-09-22 | 161 |
| K142783 | HEARTWAY Electrically Powered Wheelchair P27 | ITI | 2015-06-12 | 259 |
| K142731 | HEARTWAY Electrically Powered Wheelchairs | ITI | 2015-02-27 | 157 |
| K132855 | HEARTWAY POWER MOBILITY SCOOTER | INI | 2014-08-29 | 351 |
| K132856 | HEARTWAY POWER WHEELCHAIR | ITI | 2014-07-15 | 306 |
| K101143 | HEARTWAY POWER MOBILITY SCOOTER, S11 | INI | 2010-05-26 | 34 |
| K101142 | HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 | INI | 2010-05-26 | 34 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Heartway Medical 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Heartway Medical Products Co., Ltd.?
FDA lists 23 510(k) clearances under the applicant name “Heartway Medical Products Co., Ltd.” (first 1997, latest 2022), across 3 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 Heartway Medical Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heartway Medical Products Co., Ltd. is 46 days.
Which FDA product codes appear under Heartway Medical Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 15); ITI (Wheelchair, Powered, 7); IOR (Wheelchair, Mechanical, 1).
Next steps
- See all 23 Heartway Medical Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code INI, Heartway Medical 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, 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.