The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Attendant-controlled Power Chair, Tc1.
| Device ID | K071006 |
| 510k Number | K071006 |
| Device Name: | HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 |
| Classification | Wheelchair, Powered |
| Applicant | HEARTWAY MEDICAL PRODUCTS CO., LTD. NO.58, FU-CHIUN ST. Hsin-chu City, TW 408 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen HEARTWAY MEDICAL PRODUCTS CO., LTD. NO.58, FU-CHIUN ST. Hsin-chu City, TW 408 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-09 |
| Decision Date | 2007-05-21 |
| Summary: | summary |