The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Electrically Powered Wheelchair P27.
| Device ID | K142783 |
| 510k Number | K142783 |
| Device Name: | HEARTWAY Electrically Powered Wheelchair P27 |
| Classification | Wheelchair, Powered |
| Applicant | HEARTWAY Medical Products Co., Ltd. No.6 Road 25, Taichung Industrial Park, Taichung City, TW 40850 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min HEARTWAY Medical Products Co., Ltd. No.6 Road 25, Taichung Industrial Park, Taichung City, TW 40850 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230312 | K142783 | 000 |