The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Power Tilt Seating System Power Chair, Model# P16rt.
| Device ID | K070489 |
| 510k Number | K070489 |
| Device Name: | HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT |
| Classification | Wheelchair, Powered |
| Applicant | HEARTWAY MEDICAL PRODUCTS CO., LTD. NO.58, FU-CHIUN ST. Hsin-chu City, TW 408 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min 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 | 2007-02-20 |
| Decision Date | 2007-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230060 | K070489 | 000 |