Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Heartway Medical Products Co., Ltd. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
259 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220227 | Auto Folding Scooter, S21F | Heartway Medical Products Co., Ltd. | 2022-10-12 | 258 | 0 |
| K151656 | HEARTWAY Power Mobility Scooter | Heartway Medical Products Co., Ltd. | 2015-11-25 | 159 | 0 |
| K150998 | HEARTWAY Power Mobility Scooter | Heartway Medical Products Co., Ltd. | 2015-09-29 | 167 | 0 |
| K150987 | HEARTWAY Power Mobility Scooter, BRIO S19 | Heartway Medical Products Co., Ltd. | 2015-09-22 | 161 | 0 |
| K142783 | HEARTWAY Electrically Powered Wheelchair P27 | Heartway Medical Products Co., Ltd. | 2015-06-12 | 259 | 0 |
| K142731 | HEARTWAY Electrically Powered Wheelchairs | Heartway Medical Products Co., Ltd. | 2015-02-27 | 157 | 0 |
| K132855 | HEARTWAY POWER MOBILITY SCOOTER | Heartway Medical Products Co., Ltd. | 2014-08-29 | 351 | 0 |
| K132856 | HEARTWAY POWER WHEELCHAIR | Heartway Medical Products Co., Ltd. | 2014-07-15 | 306 | 0 |
| K101142 | HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 | Heartway Medical Products Co., Ltd. | 2010-05-26 | 34 | 0 |
| K101143 | HEARTWAY POWER MOBILITY SCOOTER, S11 | Heartway Medical Products Co., Ltd. | 2010-05-26 | 34 | 0 |
| K100327 | HEARTWAY POWER CHAIR, P23 | Heartway Medical Products Co., Ltd. | 2010-03-22 | 46 | 0 |
| K092650 | HEARTWAY POWER MOBILITY SCOOTER, S12 | Heartway Medical Products Co., Ltd. | 2009-10-09 | 43 | 0 |
| K092154 | HEARTWAY POWER MOBILITY SCOOTER, S9 | Heartway Medical Products Co., Ltd. | 2009-09-21 | 67 | 0 |
| K092155 | HEARTWAY POWER MOBILITY SCOOTER, S8 | Heartway Medical Products Co., Ltd. | 2009-09-21 | 67 | 0 |
| K080242 | HEARTWAY POWER MOBILITY SCOOTER, PF7 | Heartway Medical Products Co., Ltd. | 2008-02-27 | 27 | 0 |
| K073044 | HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 | Heartway Medical Products Co., Ltd. | 2007-12-07 | 39 | 0 |
| K072104 | HEARTWAY POWER MOBILITY SCOOTER, PF6 | Heartway Medical Products Co., Ltd. | 2007-08-17 | 17 | 0 |
| K071005 | HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 | Heartway Medical Products Co., Ltd. | 2007-05-22 | 43 | 0 |
| K071006 | HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 | Heartway Medical Products Co., Ltd. | 2007-05-21 | 42 | 0 |
| K071007 | HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 | Heartway Medical Products Co., Ltd. | 2007-04-19 | 10 | 0 |
| K070493 | HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT | Heartway Medical Products Co., Ltd. | 2007-03-23 | 31 | 0 |
| K070489 | HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT | Heartway Medical Products Co., Ltd. | 2007-03-14 | 22 | 0 |
| K973491 | MECHANICAL FOLDING WHEEL CHAIR | Heartway Medical Products Co., Ltd. | 1997-12-04 | 80 | 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