The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Power Wheelchair.
| Device ID | K132856 |
| 510k Number | K132856 |
| Device Name: | HEARTWAY POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | HEARTWAY MEDICAL PRODUCTS CO., LTD. NO. 6 ROAD 25 TAICHUNG INDUSTRIAL PARK Taichung City, Taiwan, TW R.o.c. 408 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min HEARTWAY MEDICAL PRODUCTS CO., LTD. NO. 6 ROAD 25 TAICHUNG INDUSTRIAL PARK Taichung City, Taiwan, TW R.o.c. 408 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-12 |
| Decision Date | 2014-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230107 | K132856 | 000 |